search
Back to results

First in Human Study to Assess an Implant to Treat Severe Emphysema (BREATHE-1)

Primary Purpose

Emphysema or COPD

Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Apreo Implant Group
Sponsored by
Apreo Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emphysema or COPD focused on measuring hyperinflation, air-trapping, emphysema, COPD

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 35 and ≤ 80 years old Computed tomography (CT) scan evidence of homogeneous or heterogeneous emphysema At least one target lobe with > 35% destruction (percent of voxels with < -950 Hounsfield units on CT) Post-bronchodilator ratio of FEV1/FVC < 0.7 at screening Post-bronchodilator FEV1 percent predicted ≥20% and ≤50% of predicted at screening Post-bronchodilator RV > 180% predicted Post-bronchodilator RV/TLC ≥ 0.55 at screening Marked dyspnea, scoring ≥ 2 on the modified Medical Research Council scale of 0-4 Cotinine testing at screening indicates nonsmoker and stopped smoking at least 8 weeks before entering the trial and agrees to refrain from smoking for duration of study participation Participation in a pulmonary rehabilitation program and/or confirmed to have been engaged or attempted regular physical activity in the 12 months prior to the first Apreo Procedure and agrees to continue or restart regular physical activity for the duration of the study Fully vaccinated for Covid-19 (up to date per Australian Government Guidelines) and has current pneumococcus and influenza vaccination (or documented clinical intolerance) Cognitively and physically able to provide written informed consent and complete participant questionnaires Exclusion Criteria: Arterial blood PaCO2 > 60 mmHg (8 kPa) or PaO2 ≤ 45 mmHg (6 kPa) DLCO <20% at screening Steroid therapy of 10 mg prednisolone (prednisone) or more per day Three or more acute exacerbations of COPD in the past year before enrollment Two or more hospitalizations for acute exacerbations of COPD or respiratory infections in the past year before enrollment Any acute exacerbation of COPD or respiratory infection less than 4 weeks before the first Apreo Procedure Previous lung volume reduction surgery or lobectomy, segmentectomy or bullectomy, vapor, glue, or other pulmonary device implant Known history of pulmonary arterial hypertension Presence of a giant bulla (≥ 30% of hemithorax) History of excessive dynamic airway collapse of the trachea or main bronchi History of adult asthma or chronic bronchitis Presence of suspicious pulmonary nodule/infiltrate that requires additional follow-up, diagnostics or treatment Unequivocal and symptomatic bronchiectasis Unequivocal lung cancer or other current cancer diagnosis except non-metastasized basal cell skin cancer Uncontrolled hypertension (blood pressure that is inadequately treated or resistant to treatment) with a systolic > 200 mmHg or diastolic > 110 mmHg at screening or prior to first Apreo Procedure Uncorrectable coagulopathy or other condition likely to increase risk of peri- or post- Apreo Procedure bleeding On anticoagulant or antiplatelet therapy and unable or unwilling to hold for Apreo Procedure Coronary artery disease with angina History of myocardial infarction within 6 months History of a stroke less than 1 year before the first Apreo Procedure Clinical history of heart failure with documented LVEF ≤ 40% Clinical history of diabetes with a HbA1c > 9.0% Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 (CKD-EPI) OR participant with kidney failure (Stage 5 kidney disease) Mechanical ventilator dependence except participants using nocturnal bi-level positive airway pressure (biPAP) or continuous positive airway pressure (CPAP) are allowed if it would not preclude safe implantation of the study device Pregnant, lactating, or women of childbearing potential who plan to become pregnant within the study duration Known hypersensitivity to nitinol Significantly immunocompromised, such as organ transplant recipients, those with congenital immune deficiencies, AIDS, or severe rheumatoid arthritis Any disease or condition likely to limit survival to less than one year Concomitant illnesses or medications that may pose a significant increased risk for complications following an Apreo Procedure Currently enrolled in another trial and actively receiving experimental treatment Any condition in the opinion of the investigator that would interfere with safe and complete collection of study data including the safe conduction of bronchoscopy procedures

Sites / Locations

  • Macquarie University HospitalRecruiting
  • Royal Melbourne HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apreo Implant Group

Arm Description

This group will undergo up to 2 procedures and will receive up to 3 implants during in each lung.

Outcomes

Primary Outcome Measures

Rate of Serious Adverse Events (SAE) at 6 Months
Rate of occurrence of serious adverse events related to the study device and/or study procedure through 6 months post-study procedure

Secondary Outcome Measures

Device Evaluation: Device Deployment Assessment
Evaluation of the ability to deploy the Apreo Implant in target airways (There is no scale - questions are assessed individually)
Device Evaluation: Device Usability Survey
Evaluate operator device use challenges (There is no scale - questions are assessed individually)
Device Evaluation: Instructions for Use (IFU) Survey
Evaluate operator understanding of instructions for use (There is no scale - questions are assessed individually)
Efficacy Evaluation: Airway Patency at 30 Days
Assess implant obstruction bronchoscopically using semi-quantitative scale (0 =no narrowing of the airway to 5= >75% to 100% narrowing)
Efficacy Evaluation: Airway Patency at 3 Months
Assess implant obstruction bronchoscopically using semi-quantitative scale (0 =no narrowing of the airway to 5= >75% to 100% narrowing)
Efficacy Evaluation: Airway Patency at 6 Months
Assess implant obstruction bronchoscopically using semi-quantitative scale (0 =no narrowing of the airway to 5= >75% to 100% narrowing)
Efficacy Evaluation: Airway Patency at 12 Months
Assess implant obstruction bronchoscopically using semi-quantitative scale (0 =no narrowing of the airway to 5= >75% to 100% narrowing)
Efficacy Evaluation: Mucus Assessment at 30 Days
Assess mucus within the Apreo Implant bronchoscopically using a semi-quantitative scale (0=No mucus to 5=copious mucus)
Efficacy Evaluation: Mucus Assessment at 3 Months
Assess mucus within the Apreo Implant bronchoscopically using a semi-quantitative scale (0=No mucus to 5=copious mucus)
Efficacy Evaluation: Mucus Assessment at 6 Months
Assess mucus within the Apreo Implant bronchoscopically using a semi-quantitative scale (0=No mucus to 5=copious mucus)
Efficacy Evaluation: Mucus Assessment at 12 Months
Assess mucus within the Apreo Implant bronchoscopically using a semi-quantitative scale (0=No mucus to 5=copious mucus)
Efficacy Evaluation: Computed Tomography (CT) Scan at 6 Months
CT evaluation of Apreo Implant diameter
Efficacy Evaluation: CT Scan at 12 Months
CT evaluation of Apreo Implant diameter
Efficacy Evaluation: Forced Expiratory Volume in 1 Second (FEV1) at 1-3 Days
Change in FEV1 between Baseline and 1-3 days post-procedure
Efficacy Evaluation: FEV1 at 30 Days
Change in FEV1 between Baseline and 30 days post-procedure
Efficacy Evaluation: FEV1 at 3 Months
Change in FEV1 between Baseline and 3 months post-procedure
Efficacy Evaluation: FEV1 at 6 Months
Change in FEV1 between Baseline and 6 months post-procedure
Efficacy Evaluation: FEV1 at 12 Months
Change in FEV1 between Baseline and 12 months post-procedure
Efficacy Evaluation: Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) at 6 Months
Change in DLCO between baseline and 6 months post-procedure
Efficacy Evaluation: Residual Volume (RV) at 6 Months
Change in RV between baseline and 6 months as assessed by quantitative CT
Efficacy Evaluation: Residual Volume (RV) at 12 Months
Change in RV between baseline and 12 months as assessed by quantitative CT
Efficacy Evaluation: Arterial Blood Gas (ABG): PaO2 at 6 Months
Change in PaO2 between baseline and 6 months
Efficacy Evaluation: Arterial Blood Gas (ABG): PaCO2 at 6 Months
Change in PaCO2 between baseline and 6 months
Safety: Procedural Complications
Percentage of participants with acute procedural complications within 24 hours of study procedure
Safety: Rate of SAEs
Rate of occurrence of serious adverse events related to the device and/or Apreo procedure through 12 months
Safety: Rate of Adverse Device Effects
Rate of adverse device effects through 12 months post-procedure
Efficacy Evaluation: Forced Expiratory Volume at 1 Second/ Forced Vital Capacity (FEV1/FVC) at 1-3 Days
Change in FEV1/FVC between Baseline and 1-3 days post-procedure
Efficacy Evaluation: FEV1/FVC at 30 Days
Change in FEV1/FVC between Baseline and 30 days post-procedure
Efficacy Evaluation: FEV1/FVC at 3 Months
Change in FEV1/FVC between Baseline and 3 Months post-procedure
Efficacy Evaluation: FEV1/FVC at 6 Months
Change in FEV1/FVC between Baseline and 6 Months post-procedure
Efficacy Evaluation: FEV1/FVC at 12 Months
Change in FEV1/FVC between Baseline and 12 Months post-procedure
Efficacy Evaluation: RV Assessed by Pulmonary Function Testing at 1-3 Days
Change in RV between Baseline and 1-3 Days
Efficacy Evaluation: RV Assessed by Pulmonary Function Testing at 30 Days
Change in RV between Baseline and 30 Days
Efficacy Evaluation: RV Assessed by Pulmonary Function Testing at 3 Months
Change in RV between Baseline and 3 Months
Efficacy Evaluation: RV Assessed by Pulmonary Function Testing at 6 Months
Change in RV between Baseline and 6 Months
Efficacy Evaluation: RV Assessed by Pulmonary Function Testing at 12 Months
Change in RV between Baseline and 12 Months
Efficacy Evaluation: Residual Volume/Total Lung Capacity (RV/TLC) at 1-3 Days
Change in RV/TLC between Baseline and 1-3 Days
Efficacy Evaluation: RV/TLC at 30 Days
Change in RV/TLC between Baseline and 30 Days
Efficacy Evaluation: RV/TLC at 3 Months
Change in RV/TLC between Baseline and 3 Months
Efficacy Evaluation: RV/TLC at 6 Months
Change in RV/TLC between Baseline and 6 Months
Efficacy Evaluation: RV/TLC at 12 Months
Change in RV/TLC between Baseline and 12 Months
Efficacy Evaluation: Forced Vital Capacity (FVC) at 1-3 Days
Change in FVC between Baseline and 1-3 Days
Efficacy Evaluation: FVC at 30 Days
Change in FVC between Baseline and 30 Days
Efficacy Evaluation: FVC at 3 Months
Change in FVC between Baseline and 3 Months
Efficacy Evaluation: FVC at 6 Months
Change in FVC between Baseline and 6 Months
Efficacy Evaluation: FVC at 12 Months
Change in FVC between Baseline and 12 Months
Efficacy Evaluation: Six Minute Walk Test (6MWT) at 1-3 Days
Change in 6MWT between Baseline and 1-3 Days
Efficacy Evaluation: Six Minute Walk Test (6MWT) at 30 Days
Change in 6MWT between Baseline and 30 Days
Efficacy Evaluation: Six Minute Walk Test (6MWT) at 3 Months
Change in 6MWT between Baseline and 3 Months
Efficacy Evaluation: Six Minute Walk Test (6MWT) at 6 Months
Change in 6MWT between Baseline and 6 Months
Efficacy Evaluation: Six Minute Walk Test (6MWT) at 12 Months
Change in 6MWT between Baseline and 12 Months
Efficacy Evaluation: Modified Borg Dyspnoea Scale at 1-3 Days
Change in Modified BORG Dyspnea Scale between Baseline and 1-3 Days (scale is 0= no difficulty breathing to 10=maximal difficulty)
Efficacy Evaluation: Modified Borg Dyspnoea Scale at 30 Days
Change in Modified BORG Dyspnea Scale between Baseline and 30 Days (scale is 0= no difficulty breathing to 10=maximal difficulty)
Efficacy Evaluation: Modified Borg Dyspnoea Scale at 3 Months
Change in Modified BORG Dyspnea Scale between Baseline and 3 Months (scale is 0= no difficulty breathing to 10=maximal difficulty)
Efficacy Evaluation: Modified Borg Dyspnoea Scale at 6 Months
Change in Modified BORG Dyspnea Scale between Baseline and 6 Months (scale is 0= no difficulty breathing to 10=maximal difficulty)
Efficacy Evaluation: Modified Borg Dyspnoea Scale at 12 Months
Change in Modified BORG Dyspnea Scale between Baseline and 12 Months (scale is 0= no difficulty breathing to 10=maximal difficulty)
Efficacy Evaluation: COPD Assessment Test (CAT) at 1-3 Days (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)
Change in CAT between Baseline and 1-3 Days
Efficacy Evaluation: COPD Assessment Test (CAT) at 30 Days (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)
Change in CAT between Baseline and 30 Days
Efficacy Evaluation: Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) at 3 Months (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)
Change in CAT between Baseline and 3 Months
Efficacy Evaluation: COPD Assessment Test (CAT) at 6 Months (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)
Change in CAT between Baseline and 6 Months
Efficacy Evaluation: COPD Assessment Test (CAT) at 12 Months (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)
Change in CAT between Baseline and 12 Months
Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 1-3 Days (scores range from 0 to 100, with higher scores indicating more limitations to daily living)
Change in SGRQ-C between Baseline and 1-3 Days
Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 30 Days (scores range from 0 to 100, with higher scores indicating more limitations to daily living)
Change in SGRQ-C between Baseline and 30 Days
Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 3 Months (scores range from 0 to 100, with higher scores indicating more limitations to daily living)
Change in SGRQ-C between Baseline and 3 Months
Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 6 Months (scores range from 0 to 100, with higher scores indicating more limitations to daily living)
Change in SGRQ-C between Baseline and 6 Months
Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 12 Months (scores range from 0 to 100, with higher scores indicating more limitations to daily living)
Change in SGRQ-C between Baseline and 12 Months
Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 1-3 Days
Change in mMRC between Baseline and 1-3 Days
Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 30 Days
Change in mMRC between Baseline and 30 Days
Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 3 Months
Change in mMRC between Baseline and 3 Months
Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 6 Months
Change in mMRC between Baseline and 6 Months
Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 12 Months
Change in mMRC between Baseline and 12 Months

Full Information

First Posted
April 20, 2023
Last Updated
October 2, 2023
Sponsor
Apreo Health, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05854550
Brief Title
First in Human Study to Assess an Implant to Treat Severe Emphysema
Acronym
BREATHE-1
Official Title
Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Apreo Health, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this clinical trial is to test the feasibility of an implant for severe emphysema in up to 30 participants. The main questions it aims to answer are: Is it safe? Does it work? Participants who meet eligibility criteria will have up to two procedures 30 days apart, in which up to 3 implants will be placed in each lung during the procedure(s). Participants will be asked to return for follow-up visits at 30 days, and 3, 6, and 12 months after the procedure(s).
Detailed Description
This is a first-in-human, prospective, multi-center, single-arm study assessing the safety, feasibility and preliminary efficacy of the Apreo Implant for severe emphysema in up to 30 participants. Initially all participants will undergo an Apreo Procedure involving placement of up to three implants in a native bronchial tree of one lung followed by a second Apreo Procedure 30 days later to place up to three implants in the contralateral native lung bronchial tree if indicated. Once the fifth participant has undergone his or her first implantation procedure, implantations in currently enrolled or new participants will be paused to allow for a Safety Review Committee (SRC) to convene and review safety data once the 5th participant has completed the 7-day phone follow-up after their second Apreo Procedure (or first if only one procedure). This would be at a minimum acute procedural safety for up to 10 implantation procedures conducted in these first 5 participants, 30-day safety assessments for all 5 participants after their first lung implantations, bronchoscopic inspection 30 days after implantation of all implants in the first lung, and 7-day safety data after their first and second lung implantations. The SRC will provide comments and recommendations, including the restart of implantation for new participants, if deemed appropriate. After the first 10 participants have completed the 7-day phone follow-up after the second Apreo Procedure (or first if only one procedure), their safety data will be reviewed by the SRC. This would include at a minimum acute procedural safety for up to 20 implantation procedures conducted in these first 10 participants, 30-day safety assessments for all 10 participants after their first lung implantations, bronchoscopic inspection 30 days after implantation of all implants in the first lung, and 7-day safety data after their first and second lung implantations. Following the review of the first 10 participants' safety data, the SRC may allow any subsequently enrolled participants to undergo one Apreo Procedure (rather than two separate procedures if appropriate for a participant) to deploy Apreo Implants in both the left and right lung airways as indicated or to continue to have all participants undergo two separate Apreo Procedures if indicated. A total of up to 30 participants will be enrolled overall. All participants will be followed at 30 days, three, six and twelve months post the first Apreo Procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emphysema or COPD
Keywords
hyperinflation, air-trapping, emphysema, COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Apreo Implant Group
Arm Type
Experimental
Arm Description
This group will undergo up to 2 procedures and will receive up to 3 implants during in each lung.
Intervention Type
Device
Intervention Name(s)
Apreo Implant Group
Intervention Description
One or two procedures involving placement of up to three Apreo implants in the bronchial tree of each lung.
Primary Outcome Measure Information:
Title
Rate of Serious Adverse Events (SAE) at 6 Months
Description
Rate of occurrence of serious adverse events related to the study device and/or study procedure through 6 months post-study procedure
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Device Evaluation: Device Deployment Assessment
Description
Evaluation of the ability to deploy the Apreo Implant in target airways (There is no scale - questions are assessed individually)
Time Frame
During Procedure
Title
Device Evaluation: Device Usability Survey
Description
Evaluate operator device use challenges (There is no scale - questions are assessed individually)
Time Frame
During Procedure
Title
Device Evaluation: Instructions for Use (IFU) Survey
Description
Evaluate operator understanding of instructions for use (There is no scale - questions are assessed individually)
Time Frame
During Procedure
Title
Efficacy Evaluation: Airway Patency at 30 Days
Description
Assess implant obstruction bronchoscopically using semi-quantitative scale (0 =no narrowing of the airway to 5= >75% to 100% narrowing)
Time Frame
30 Days
Title
Efficacy Evaluation: Airway Patency at 3 Months
Description
Assess implant obstruction bronchoscopically using semi-quantitative scale (0 =no narrowing of the airway to 5= >75% to 100% narrowing)
Time Frame
3 Months
Title
Efficacy Evaluation: Airway Patency at 6 Months
Description
Assess implant obstruction bronchoscopically using semi-quantitative scale (0 =no narrowing of the airway to 5= >75% to 100% narrowing)
Time Frame
6 Months
Title
Efficacy Evaluation: Airway Patency at 12 Months
Description
Assess implant obstruction bronchoscopically using semi-quantitative scale (0 =no narrowing of the airway to 5= >75% to 100% narrowing)
Time Frame
12 Months
Title
Efficacy Evaluation: Mucus Assessment at 30 Days
Description
Assess mucus within the Apreo Implant bronchoscopically using a semi-quantitative scale (0=No mucus to 5=copious mucus)
Time Frame
30 Days
Title
Efficacy Evaluation: Mucus Assessment at 3 Months
Description
Assess mucus within the Apreo Implant bronchoscopically using a semi-quantitative scale (0=No mucus to 5=copious mucus)
Time Frame
3 Months
Title
Efficacy Evaluation: Mucus Assessment at 6 Months
Description
Assess mucus within the Apreo Implant bronchoscopically using a semi-quantitative scale (0=No mucus to 5=copious mucus)
Time Frame
6 Months
Title
Efficacy Evaluation: Mucus Assessment at 12 Months
Description
Assess mucus within the Apreo Implant bronchoscopically using a semi-quantitative scale (0=No mucus to 5=copious mucus)
Time Frame
12 Months
Title
Efficacy Evaluation: Computed Tomography (CT) Scan at 6 Months
Description
CT evaluation of Apreo Implant diameter
Time Frame
6 Months
Title
Efficacy Evaluation: CT Scan at 12 Months
Description
CT evaluation of Apreo Implant diameter
Time Frame
12 Months
Title
Efficacy Evaluation: Forced Expiratory Volume in 1 Second (FEV1) at 1-3 Days
Description
Change in FEV1 between Baseline and 1-3 days post-procedure
Time Frame
1-3 Days
Title
Efficacy Evaluation: FEV1 at 30 Days
Description
Change in FEV1 between Baseline and 30 days post-procedure
Time Frame
30 Days
Title
Efficacy Evaluation: FEV1 at 3 Months
Description
Change in FEV1 between Baseline and 3 months post-procedure
Time Frame
3 Months
Title
Efficacy Evaluation: FEV1 at 6 Months
Description
Change in FEV1 between Baseline and 6 months post-procedure
Time Frame
6 Months
Title
Efficacy Evaluation: FEV1 at 12 Months
Description
Change in FEV1 between Baseline and 12 months post-procedure
Time Frame
12 Months
Title
Efficacy Evaluation: Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) at 6 Months
Description
Change in DLCO between baseline and 6 months post-procedure
Time Frame
6 Months
Title
Efficacy Evaluation: Residual Volume (RV) at 6 Months
Description
Change in RV between baseline and 6 months as assessed by quantitative CT
Time Frame
6 Months
Title
Efficacy Evaluation: Residual Volume (RV) at 12 Months
Description
Change in RV between baseline and 12 months as assessed by quantitative CT
Time Frame
12 Months
Title
Efficacy Evaluation: Arterial Blood Gas (ABG): PaO2 at 6 Months
Description
Change in PaO2 between baseline and 6 months
Time Frame
6 Months
Title
Efficacy Evaluation: Arterial Blood Gas (ABG): PaCO2 at 6 Months
Description
Change in PaCO2 between baseline and 6 months
Time Frame
6 Months
Title
Safety: Procedural Complications
Description
Percentage of participants with acute procedural complications within 24 hours of study procedure
Time Frame
Through 24 hours post-procedure
Title
Safety: Rate of SAEs
Description
Rate of occurrence of serious adverse events related to the device and/or Apreo procedure through 12 months
Time Frame
Through 12 Months
Title
Safety: Rate of Adverse Device Effects
Description
Rate of adverse device effects through 12 months post-procedure
Time Frame
Through 12 Months
Title
Efficacy Evaluation: Forced Expiratory Volume at 1 Second/ Forced Vital Capacity (FEV1/FVC) at 1-3 Days
Description
Change in FEV1/FVC between Baseline and 1-3 days post-procedure
Time Frame
1-3 Days
Title
Efficacy Evaluation: FEV1/FVC at 30 Days
Description
Change in FEV1/FVC between Baseline and 30 days post-procedure
Time Frame
30 Days
Title
Efficacy Evaluation: FEV1/FVC at 3 Months
Description
Change in FEV1/FVC between Baseline and 3 Months post-procedure
Time Frame
3 Months
Title
Efficacy Evaluation: FEV1/FVC at 6 Months
Description
Change in FEV1/FVC between Baseline and 6 Months post-procedure
Time Frame
6 Months
Title
Efficacy Evaluation: FEV1/FVC at 12 Months
Description
Change in FEV1/FVC between Baseline and 12 Months post-procedure
Time Frame
12 Months
Title
Efficacy Evaluation: RV Assessed by Pulmonary Function Testing at 1-3 Days
Description
Change in RV between Baseline and 1-3 Days
Time Frame
1-3 Days
Title
Efficacy Evaluation: RV Assessed by Pulmonary Function Testing at 30 Days
Description
Change in RV between Baseline and 30 Days
Time Frame
30 Days
Title
Efficacy Evaluation: RV Assessed by Pulmonary Function Testing at 3 Months
Description
Change in RV between Baseline and 3 Months
Time Frame
3 Months
Title
Efficacy Evaluation: RV Assessed by Pulmonary Function Testing at 6 Months
Description
Change in RV between Baseline and 6 Months
Time Frame
6 Months
Title
Efficacy Evaluation: RV Assessed by Pulmonary Function Testing at 12 Months
Description
Change in RV between Baseline and 12 Months
Time Frame
12 Months
Title
Efficacy Evaluation: Residual Volume/Total Lung Capacity (RV/TLC) at 1-3 Days
Description
Change in RV/TLC between Baseline and 1-3 Days
Time Frame
1-3 Days
Title
Efficacy Evaluation: RV/TLC at 30 Days
Description
Change in RV/TLC between Baseline and 30 Days
Time Frame
30 Days
Title
Efficacy Evaluation: RV/TLC at 3 Months
Description
Change in RV/TLC between Baseline and 3 Months
Time Frame
3 Months
Title
Efficacy Evaluation: RV/TLC at 6 Months
Description
Change in RV/TLC between Baseline and 6 Months
Time Frame
6 Months
Title
Efficacy Evaluation: RV/TLC at 12 Months
Description
Change in RV/TLC between Baseline and 12 Months
Time Frame
12 Months
Title
Efficacy Evaluation: Forced Vital Capacity (FVC) at 1-3 Days
Description
Change in FVC between Baseline and 1-3 Days
Time Frame
1-3 Days
Title
Efficacy Evaluation: FVC at 30 Days
Description
Change in FVC between Baseline and 30 Days
Time Frame
30 Days
Title
Efficacy Evaluation: FVC at 3 Months
Description
Change in FVC between Baseline and 3 Months
Time Frame
3 Months
Title
Efficacy Evaluation: FVC at 6 Months
Description
Change in FVC between Baseline and 6 Months
Time Frame
6 Months
Title
Efficacy Evaluation: FVC at 12 Months
Description
Change in FVC between Baseline and 12 Months
Time Frame
12 Months
Title
Efficacy Evaluation: Six Minute Walk Test (6MWT) at 1-3 Days
Description
Change in 6MWT between Baseline and 1-3 Days
Time Frame
1-3 Days
Title
Efficacy Evaluation: Six Minute Walk Test (6MWT) at 30 Days
Description
Change in 6MWT between Baseline and 30 Days
Time Frame
30 Days
Title
Efficacy Evaluation: Six Minute Walk Test (6MWT) at 3 Months
Description
Change in 6MWT between Baseline and 3 Months
Time Frame
3 Months
Title
Efficacy Evaluation: Six Minute Walk Test (6MWT) at 6 Months
Description
Change in 6MWT between Baseline and 6 Months
Time Frame
6 Months
Title
Efficacy Evaluation: Six Minute Walk Test (6MWT) at 12 Months
Description
Change in 6MWT between Baseline and 12 Months
Time Frame
12 Months
Title
Efficacy Evaluation: Modified Borg Dyspnoea Scale at 1-3 Days
Description
Change in Modified BORG Dyspnea Scale between Baseline and 1-3 Days (scale is 0= no difficulty breathing to 10=maximal difficulty)
Time Frame
1-3 Days
Title
Efficacy Evaluation: Modified Borg Dyspnoea Scale at 30 Days
Description
Change in Modified BORG Dyspnea Scale between Baseline and 30 Days (scale is 0= no difficulty breathing to 10=maximal difficulty)
Time Frame
30 Days
Title
Efficacy Evaluation: Modified Borg Dyspnoea Scale at 3 Months
Description
Change in Modified BORG Dyspnea Scale between Baseline and 3 Months (scale is 0= no difficulty breathing to 10=maximal difficulty)
Time Frame
3 Months
Title
Efficacy Evaluation: Modified Borg Dyspnoea Scale at 6 Months
Description
Change in Modified BORG Dyspnea Scale between Baseline and 6 Months (scale is 0= no difficulty breathing to 10=maximal difficulty)
Time Frame
6 Months
Title
Efficacy Evaluation: Modified Borg Dyspnoea Scale at 12 Months
Description
Change in Modified BORG Dyspnea Scale between Baseline and 12 Months (scale is 0= no difficulty breathing to 10=maximal difficulty)
Time Frame
12 Months
Title
Efficacy Evaluation: COPD Assessment Test (CAT) at 1-3 Days (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)
Description
Change in CAT between Baseline and 1-3 Days
Time Frame
1-3 Days
Title
Efficacy Evaluation: COPD Assessment Test (CAT) at 30 Days (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)
Description
Change in CAT between Baseline and 30 Days
Time Frame
30 Days
Title
Efficacy Evaluation: Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) at 3 Months (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)
Description
Change in CAT between Baseline and 3 Months
Time Frame
3 Months
Title
Efficacy Evaluation: COPD Assessment Test (CAT) at 6 Months (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)
Description
Change in CAT between Baseline and 6 Months
Time Frame
6 Months
Title
Efficacy Evaluation: COPD Assessment Test (CAT) at 12 Months (CAT scores range from 0 to 40, with higher score denoting higher impact of COPD on a participant's life)
Description
Change in CAT between Baseline and 12 Months
Time Frame
12 Months
Title
Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 1-3 Days (scores range from 0 to 100, with higher scores indicating more limitations to daily living)
Description
Change in SGRQ-C between Baseline and 1-3 Days
Time Frame
1-3 Days
Title
Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 30 Days (scores range from 0 to 100, with higher scores indicating more limitations to daily living)
Description
Change in SGRQ-C between Baseline and 30 Days
Time Frame
30 Days
Title
Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 3 Months (scores range from 0 to 100, with higher scores indicating more limitations to daily living)
Description
Change in SGRQ-C between Baseline and 3 Months
Time Frame
3 Months
Title
Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 6 Months (scores range from 0 to 100, with higher scores indicating more limitations to daily living)
Description
Change in SGRQ-C between Baseline and 6 Months
Time Frame
6 Months
Title
Efficacy Evaluation: St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at 12 Months (scores range from 0 to 100, with higher scores indicating more limitations to daily living)
Description
Change in SGRQ-C between Baseline and 12 Months
Time Frame
12 Months
Title
Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 1-3 Days
Description
Change in mMRC between Baseline and 1-3 Days
Time Frame
1-3 Days
Title
Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 30 Days
Description
Change in mMRC between Baseline and 30 Days
Time Frame
30 Days
Title
Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 3 Months
Description
Change in mMRC between Baseline and 3 Months
Time Frame
3 Months
Title
Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 6 Months
Description
Change in mMRC between Baseline and 6 Months
Time Frame
6 Months
Title
Efficacy Evaluation: Modified Medical Research Council (mMRC) Dyspnea Scale (0=no breathlessness except with strenuous exercise to 4=too breathless to leave the house or breathless when dressing or undressing) at 12 Months
Description
Change in mMRC between Baseline and 12 Months
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 35 and ≤ 80 years old Computed tomography (CT) scan evidence of homogeneous or heterogeneous emphysema At least one target lobe with > 35% destruction (percent of voxels with < -950 Hounsfield units on CT) Post-bronchodilator ratio of FEV1/FVC < 0.7 at screening Post-bronchodilator FEV1 percent predicted ≥20% and ≤50% of predicted at screening Post-bronchodilator RV > 180% predicted Post-bronchodilator RV/TLC ≥ 0.55 at screening Marked dyspnea, scoring ≥ 2 on the modified Medical Research Council scale of 0-4 Cotinine testing at screening indicates nonsmoker and stopped smoking at least 8 weeks before entering the trial and agrees to refrain from smoking for duration of study participation Participation in a pulmonary rehabilitation program and/or confirmed to have been engaged or attempted regular physical activity in the 12 months prior to the first Apreo Procedure and agrees to continue or restart regular physical activity for the duration of the study Fully vaccinated for Covid-19 (up to date per Australian Government Guidelines) and has current pneumococcus and influenza vaccination (or documented clinical intolerance) Cognitively and physically able to provide written informed consent and complete participant questionnaires Exclusion Criteria: Arterial blood PaCO2 > 60 mmHg (8 kPa) or PaO2 ≤ 45 mmHg (6 kPa) DLCO <20% at screening Steroid therapy of 10 mg prednisolone (prednisone) or more per day Three or more acute exacerbations of COPD in the past year before enrollment Two or more hospitalizations for acute exacerbations of COPD or respiratory infections in the past year before enrollment Any acute exacerbation of COPD or respiratory infection less than 4 weeks before the first Apreo Procedure Previous lung volume reduction surgery or lobectomy, segmentectomy or bullectomy, vapor, glue, or other pulmonary device implant Known history of pulmonary arterial hypertension Presence of a giant bulla (≥ 30% of hemithorax) History of excessive dynamic airway collapse of the trachea or main bronchi History of adult asthma or chronic bronchitis Presence of suspicious pulmonary nodule/infiltrate that requires additional follow-up, diagnostics or treatment Unequivocal and symptomatic bronchiectasis Unequivocal lung cancer or other current cancer diagnosis except non-metastasized basal cell skin cancer Uncontrolled hypertension (blood pressure that is inadequately treated or resistant to treatment) with a systolic > 200 mmHg or diastolic > 110 mmHg at screening or prior to first Apreo Procedure Uncorrectable coagulopathy or other condition likely to increase risk of peri- or post- Apreo Procedure bleeding On anticoagulant or antiplatelet therapy and unable or unwilling to hold for Apreo Procedure Coronary artery disease with angina History of myocardial infarction within 6 months History of a stroke less than 1 year before the first Apreo Procedure Clinical history of heart failure with documented LVEF ≤ 40% Clinical history of diabetes with a HbA1c > 9.0% Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 (CKD-EPI) OR participant with kidney failure (Stage 5 kidney disease) Mechanical ventilator dependence except participants using nocturnal bi-level positive airway pressure (biPAP) or continuous positive airway pressure (CPAP) are allowed if it would not preclude safe implantation of the study device Pregnant, lactating, or women of childbearing potential who plan to become pregnant within the study duration Known hypersensitivity to nitinol Significantly immunocompromised, such as organ transplant recipients, those with congenital immune deficiencies, AIDS, or severe rheumatoid arthritis Any disease or condition likely to limit survival to less than one year Concomitant illnesses or medications that may pose a significant increased risk for complications following an Apreo Procedure Currently enrolled in another trial and actively receiving experimental treatment Any condition in the opinion of the investigator that would interfere with safe and complete collection of study data including the safe conduction of bronchoscopy procedures
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shirin Hasan
Phone
+1 408-250-5881
Email
shasan@thefoundry.com
First Name & Middle Initial & Last Name or Official Title & Degree
Karun Naga
Phone
+1 310-709-1818
Email
karun@thefoundry.com
Facility Information:
Facility Name
Macquarie University Hospital
City
Macquarie
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Callum Rutherford
Phone
+61 434 949 605
Email
callum.rutherford@mq.edu.au
First Name & Middle Initial & Last Name & Degree
Alvin Ing, Prof
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jemma Christie
Phone
+61 417 005 117
Email
Jemma.Christie@mh.org.au
First Name & Middle Initial & Last Name & Degree
Daniel Steinfort, A/Prof

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

First in Human Study to Assess an Implant to Treat Severe Emphysema

We'll reach out to this number within 24 hrs