Mind The Gap - Crossing Borders Study

Study Overview
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Brief Summary
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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.

Official Title
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Bronchoscopic Conversion of Collateral Ventilation in CV-positive Emphysema Patients Before Endobronchial Valve Treatment - Mind The Gap Crossing Borders Study

Conditions
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Emphysema, COPD, Hyperinflation Lung

Intervention / Treatment
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* Device: Bronchoscopic transparenchymal interlobar fissure closure using Aeriseal


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Treatment group | Device: Bronchoscopic transparenchymal interlobar fissure closure using Aeriseal<br>* Transbronchial or transparenchymal injection of AeriSeal into the interlobar collateral ventilation channels region to convert CV-positive lobes into CV-negative lobes.<br>* Other names: Aeriseal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 
| 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) | 3 months | 
| effectiveness - Measurement of change in Forced Expiratory Volume in one second (FEV1). | By measuring changes in relative% in FEV1(L) | 3 months | 
| effectiveness - Measurement of change in Residual Volume (RV) | By measuring the change in absolute mL in RV | 3 months | 
| effectiveness - Measurement of changes in 6-minute walk test (6MWT) | By measuring the absolute change in meters in the 6MWT | 3 months | 
| 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) | 3 months |