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Mind The Gap - Crossing Borders Study

Primary Purpose

Emphysema, COPD, Hyperinflation Lung

Status
Active
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Bronchoscopic transparenchymal interlobar fissure closure using Aeriseal
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emphysema

Eligibility Criteria

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

Inclusion Criteria:

  1. Diagnosis of emphysema with a treatable target for endobronchial valves (Zephyr).
  2. Subjects of both genders of at least 35 years of age at the time of the baseline visit.
  3. Understand and voluntarily sign a patient informed consent form.
  4. 15 % predicted ≤ FEV1 ≤ 50% predicted.
  5. RV ≥ 175% predicted, and TLC ≥ 100% predicted and RV/TLC ≥ 55%.
  6. 6MWD ≥ 140 meters.
  7. Dyspnea score of ≥2 on the mMRC scale of 0-4.
  8. Non-smoker > 6 months prior to signing the informed consent.
  9. Chartis CV positive between target and ipsilateral lobe

Exclusion Criteria:

  1. Evidence of active pulmonary infection.
  2. Evidence of clinically significant bronchiectasis.
  3. History of more than 3 exacerbations with hospitalizations over the past 12 months.
  4. Myocardial infarction or other relevant cardiovascular events in the past 6 months.
  5. Prior lung surgery, Lung volume reduction surgery, lung transplantation, lobectomy, or pneumonectomy.
  6. Prior endoscopic lung volume reduction.
  7. Unstable pulmonary nodule requiring follow-up
  8. Pregnant of nursing women.
  9. Hypercapnia defined by PaCO2 > 8.0kPa, or Hypoxemia defined by PaO2 < 6.0kPa, both measured on room air.
  10. Any disease with high probability of mortality within 24 months.
  11. Patient is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such as LMWH or coumarins), which cannot be stopped periprocedural.
  12. Patient was involved in other pulmonary drug studies within 30 days prior to this study.

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Sites / Locations

  • University Medical Center Groningen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

Treatment group

Outcomes

Primary Outcome Measures

feasibility - Target Lobar Volume Change on Chest -CT scan
To investigate the feasibility of injecting AeriSeal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment

Secondary Outcome Measures

safety - Number and specification of reported (S)AEs per individual patient and as aggregate
To investigate the safety of injecting AeriSeal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment. Thsi by collection of all adverse events, and specifically: death, pnuemothorax, pneumonia, COPD exacerbation, and post treatment inflammatory response.
changes in Quality of Life as measured by the SGRQ
By measuring the absolute change in The St George's Respiratory Questionnaire total score (0-100 points with higher scores indicating poor QOL)
effectiveness - Measurement of change in Forced Expiratory Volume in one second (FEV1).
By measuring changes in relative% in FEV1(L)
effectiveness - Measurement of change in Residual Volume (RV)
By measuring the change in absolute mL in RV
effectiveness - Measurement of changes in 6-minute walk test (6MWT)
By measuring the absolute change in meters in the 6MWT
changes in Quality of Life as measured by the COPD Assessment Test (CAT)
By measuring the absolute change in CAT score (0-40, with higher score indicating poor QOL)

Full Information

First Posted
January 20, 2020
Last Updated
October 17, 2022
Sponsor
University Medical Center Groningen
Collaborators
Pulmonx Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04256408
Brief Title
Mind The Gap - Crossing Borders Study
Official Title
Bronchoscopic Conversion of Collateral Ventilation in CV-positive Emphysema Patients Before Endobronchial Valve Treatment - Mind The Gap Crossing Borders Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
January 2, 2023 (Anticipated)
Study Completion Date
September 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen
Collaborators
Pulmonx Corporation

4. Oversight

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

5. Study Description

Brief Summary
Rationale: A big step forward and great opportunity to improve overall efficacy of bronchoscopic lung volume reductioen is to combine treatment modalities aiming to close the dependent collateral channels and then proceed with EBV therapy to induce lobar collapse, and thus maximal treatment effect. Objective: Primary objective: To investigate the feasibility of injecting AeriSeal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment. Secondary objectives: To investigate the safety of injecting AeriSeal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment. To investigate the effectiveness of injecting AeriSeal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emphysema, COPD, Hyperinflation Lung

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Treatment group
Intervention Type
Device
Intervention Name(s)
Bronchoscopic transparenchymal interlobar fissure closure using Aeriseal
Other Intervention Name(s)
Aeriseal
Intervention Description
Transbronchial or transparenchymal injection of AeriSeal into the interlobar collateral ventilation channels region to convert CV-positive lobes into CV-negative lobes.
Primary Outcome Measure Information:
Title
feasibility - Target Lobar Volume Change on Chest -CT scan
Description
To investigate the feasibility of injecting AeriSeal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment
Time Frame
3 months
Secondary Outcome Measure Information:
Title
safety - Number and specification of reported (S)AEs per individual patient and as aggregate
Description
To investigate the safety of injecting AeriSeal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment. Thsi by collection of all adverse events, and specifically: death, pnuemothorax, pneumonia, COPD exacerbation, and post treatment inflammatory response.
Time Frame
3 months
Title
changes in Quality of Life as measured by the SGRQ
Description
By measuring the absolute change in The St George's Respiratory Questionnaire total score (0-100 points with higher scores indicating poor QOL)
Time Frame
3 months
Title
effectiveness - Measurement of change in Forced Expiratory Volume in one second (FEV1).
Description
By measuring changes in relative% in FEV1(L)
Time Frame
3 months
Title
effectiveness - Measurement of change in Residual Volume (RV)
Description
By measuring the change in absolute mL in RV
Time Frame
3 months
Title
effectiveness - Measurement of changes in 6-minute walk test (6MWT)
Description
By measuring the absolute change in meters in the 6MWT
Time Frame
3 months
Title
changes in Quality of Life as measured by the COPD Assessment Test (CAT)
Description
By measuring the absolute change in CAT score (0-40, with higher score indicating poor QOL)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of emphysema with a treatable target for endobronchial valves (Zephyr). Subjects of both genders of at least 35 years of age at the time of the baseline visit. Understand and voluntarily sign a patient informed consent form. 15 % predicted ≤ FEV1 ≤ 50% predicted. RV ≥ 175% predicted, and TLC ≥ 100% predicted and RV/TLC ≥ 55%. 6MWD ≥ 140 meters. Dyspnea score of ≥2 on the mMRC scale of 0-4. Non-smoker > 6 months prior to signing the informed consent. Chartis CV positive between target and ipsilateral lobe Exclusion Criteria: Evidence of active pulmonary infection. Evidence of clinically significant bronchiectasis. History of more than 3 exacerbations with hospitalizations over the past 12 months. Myocardial infarction or other relevant cardiovascular events in the past 6 months. Prior lung surgery, Lung volume reduction surgery, lung transplantation, lobectomy, or pneumonectomy. Prior endoscopic lung volume reduction. Unstable pulmonary nodule requiring follow-up Pregnant of nursing women. Hypercapnia defined by PaCO2 > 8.0kPa, or Hypoxemia defined by PaO2 < 6.0kPa, both measured on room air. Any disease with high probability of mortality within 24 months. Patient is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such as LMWH or coumarins), which cannot be stopped periprocedural. Patient was involved in other pulmonary drug studies within 30 days prior to this study. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin Klooster, PhD
Organizational Affiliation
UMC-Groningen/NL
Official's Role
Study Director
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9700RB
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

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Mind The Gap - Crossing Borders Study

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