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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

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:

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.
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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

NCT ID

NCT04256408

First Posted

January 20, 2020

Last Updated

October 17, 2022

Sponsor

University Medical Center Groningen

Collaborators

Pulmonx Corporation

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

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

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Mind The Gap - Crossing Borders Study

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