Back to resultsEvaluation of the Free Flow Medical Lung Tensioning Device System for the Treatment of Severe Emphysema (EFFORT)
Primary Purpose
Emphysema or COPD
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
FreeFlowMedical Lung Tensioning Device
Sponsored by
About this trial
This is an interventional treatment trial for Emphysema or COPD focused on measuring lung volume reduction, nitinol, device
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of COPD
- FEV1/FVC ≤ 70%
- ≥ 40 years of age
- Post-bronchodilator FEV1 ≤ 45% of predicted
- Total Lung Capacity > 100% of predicted
- Residual Volume (RV) > 175% of predicted
- RV/TLC > 55%
- Marked dyspnea defined by a score of ≥ 2 on mMRC dyspnea scale of 0-4
- Emphysema with ≥ 20% destruction (on -950 Hounsfield units) of two potential treatment lobe(s)
- Stopped smoking for ≥ 6 months prior to entering the study
- Completed a pulmonary rehabilitation program prior to entering the study and/or have regular (at least once a week) physiotherapy
- Ability to read, understand and sign the informed consent form
Exclusion Criteria:
- History of recurrent clinically significant respiratory infections and/or COPD exacerbations, defined as ≥ 2 hospitalizations for respiratory infections and/or COPD exacerbations during the year prior to enrolment
- History of recurrent clinically significant respiratory infections and/or COPD exacerbations, defined as ≥ 3 courses of prednisolone and/or antibiotics for respiratory infections and/or COPD exacerbations during the year prior to enrolment
- Clinically significant bronchiectasis
- Severe gas exchange abnormalities defined by PaCO2 > 7.0 kPa (52 mmHg) and/or PaO2 < 7.0 kPa (52 mmHg) (measured on room air)
- ≥ 10 mg prednisone (or equivalent dose of other corticosteroids) daily
- Inability to walk > 140 meters in 6 minutes
- Known pulmonary hypertension defined by right ventricular systolic pressure > 45 mmHg and/or evidence of pulmonary hypertension of right ventricular failure on echocardiogram
- Significant paraseptal emphysema
- Giant bullae (>1/3 of lung volume)
- Medical history of asthma
- Underwent previous LVRS, lobectomy, pneumonectomy or lung transplant
- Underwent previous treatment with thermal vapor ablation, AeriSeal, Cryospray, endobronchial coils or endobronchial valves (if still implanted)
- Evidence of other disease(s) that have a predicted survival of less than one year
- Inability to tolerate bronchoscopy under general anaesthesia
- Maintenance antiplatelet (except aspirin/Ascal) or anticoagulant therapy (such as warfarin, Coumadin, heparin, LMWH, DOACs, etc) which cannot be permanently stopped prior to entering the study
- Pregnant, lactating or plans to become pregnant within the study timeframe
- Known sensitivity to drugs required to perform bronchoscopy under general anaesthesia
- Any other disease, condition(s) or habit(s) that would interfere with completion of study and follow up assessments, would increase risks of bronchoscopy or assessments or in the judgment of the investigator would potentially interfere
- Known Nickel, Titanium, or Nitinol allergy
Sites / Locations
- Dept. of Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg
- University Medical Center GroningenRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment group
Arm Description
Bronchoscopic LTD placement
Outcomes
Primary Outcome Measures
Safety: type and frequency of device-related and procedure-related AE
To evaluate the safety of the LTD in COPD patients with heterogeneous and homogeneous emphysema by evaluating the type and frequency of device-related and procedure-related AE experienced during and following LTD placement through the 3-month visit.
Procedural succes
To evaluate the feasibility of the LTD in COPD patients with heterogeneous and homogeneous emphysema by measuring the frequencies of successful and unsuccessful intended LTD placements.
Secondary Outcome Measures
Performance - Quality of Life: St George's Respiratory Questionnaire
Change in St George's Respiratory Questionnaire total score
Full Information
NCT ID
NCT04520152
First Posted
August 17, 2020
Last Updated
September 28, 2021
Sponsor
University Medical Center Groningen
1. Study Identification
Unique Protocol Identification Number
NCT04520152
Brief Title
Evaluation of the Free Flow Medical Lung Tensioning Device System for the Treatment of Severe Emphysema
Acronym
EFFORT
Official Title
Evaluation of the Free Flow Medical Lung Tensioning Device System for the Treatment of Severe Emphysema - EFFORT
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 23, 2021 (Actual)
Primary Completion Date
October 2, 2022 (Anticipated)
Study Completion Date
December 2, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen
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
Patients with severe emphysema have limited options for treatment. Current treatments include lung transplant, lung volume reduction surgery or endobronchial lung volume reduction using valves or coils. These options are only available for a small and selected group of patients. The Free Flow Medical Lung Tensioning Device System (LTD) is thought to be the next generation endobronchial treatment for patients with severe emphysema designed to address this unmet need. The LTD is designed to compress the areas of lung parenchyma most damaged by emphysema and to tension surrounding tissue to help restore lung elastic recoil in a similar manner to the lung volume reduction coils.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emphysema or COPD
Keywords
lung volume reduction, nitinol, device
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Bronchoscopic LTD placement
Intervention Type
Device
Intervention Name(s)
FreeFlowMedical Lung Tensioning Device
Intervention Description
Bronchoscopic lung tensioning device implantation
Primary Outcome Measure Information:
Title
Safety: type and frequency of device-related and procedure-related AE
Description
To evaluate the safety of the LTD in COPD patients with heterogeneous and homogeneous emphysema by evaluating the type and frequency of device-related and procedure-related AE experienced during and following LTD placement through the 3-month visit.
Time Frame
3 months
Title
Procedural succes
Description
To evaluate the feasibility of the LTD in COPD patients with heterogeneous and homogeneous emphysema by measuring the frequencies of successful and unsuccessful intended LTD placements.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Performance - Quality of Life: St George's Respiratory Questionnaire
Description
Change in St George's Respiratory Questionnaire total score
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of COPD
FEV1/FVC ≤ 70%
≥ 40 years of age
Post-bronchodilator FEV1 ≤ 45% of predicted
Total Lung Capacity > 100% of predicted
Residual Volume (RV) > 175% of predicted
RV/TLC > 55%
Marked dyspnea defined by a score of ≥ 2 on mMRC dyspnea scale of 0-4
Emphysema with ≥ 20% destruction (on -950 Hounsfield units) of two potential treatment lobe(s)
Stopped smoking for ≥ 6 months prior to entering the study
Completed a pulmonary rehabilitation program prior to entering the study and/or have regular (at least once a week) physiotherapy
Ability to read, understand and sign the informed consent form
Exclusion Criteria:
History of recurrent clinically significant respiratory infections and/or COPD exacerbations, defined as ≥ 2 hospitalizations for respiratory infections and/or COPD exacerbations during the year prior to enrolment
History of recurrent clinically significant respiratory infections and/or COPD exacerbations, defined as ≥ 3 courses of prednisolone and/or antibiotics for respiratory infections and/or COPD exacerbations during the year prior to enrolment
Clinically significant bronchiectasis
Severe gas exchange abnormalities defined by PaCO2 > 7.0 kPa (52 mmHg) and/or PaO2 < 7.0 kPa (52 mmHg) (measured on room air)
≥ 10 mg prednisone (or equivalent dose of other corticosteroids) daily
Inability to walk > 140 meters in 6 minutes
Known pulmonary hypertension defined by right ventricular systolic pressure > 45 mmHg and/or evidence of pulmonary hypertension of right ventricular failure on echocardiogram
Significant paraseptal emphysema
Giant bullae (>1/3 of lung volume)
Medical history of asthma
Underwent previous LVRS, lobectomy, pneumonectomy or lung transplant
Underwent previous treatment with thermal vapor ablation, AeriSeal, Cryospray, endobronchial coils or endobronchial valves (if still implanted)
Evidence of other disease(s) that have a predicted survival of less than one year
Inability to tolerate bronchoscopy under general anaesthesia
Maintenance antiplatelet (except aspirin/Ascal) or anticoagulant therapy (such as warfarin, Coumadin, heparin, LMWH, DOACs, etc) which cannot be permanently stopped prior to entering the study
Pregnant, lactating or plans to become pregnant within the study timeframe
Known sensitivity to drugs required to perform bronchoscopy under general anaesthesia
Any other disease, condition(s) or habit(s) that would interfere with completion of study and follow up assessments, would increase risks of bronchoscopy or assessments or in the judgment of the investigator would potentially interfere
Known Nickel, Titanium, or Nitinol allergy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sharyn Roodenburg, MD, MSc
Phone
+31503616161
Email
s.a.roodenburg@umcg.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Karin Klooster, PhD
Phone
+31503616161
Email
k.klooster@umcg.nl
Facility Information:
Facility Name
Dept. of Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
D-69126
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralph Eberhardt, MD PhD
Email
Ralf.eberhardt@med.uni-heidelberg.de
First Name & Middle Initial & Last Name & Degree
Ralph Eberhardt, MD PhD
First Name & Middle Initial & Last Name & Degree
Felix Herth, MD PhD
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9700RB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharyn Roodenburg, MD, MSc
Phone
+31503616161
Email
s.a.roodenburg@umcg.nl
First Name & Middle Initial & Last Name & Degree
Dirk-Jan Slebos, MD PhD
First Name & Middle Initial & Last Name & Degree
David Koster, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Free Flow Medical Lung Tensioning Device System for the Treatment of Severe Emphysema
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