Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction

Study Overview
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Brief Summary
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To assess the safety and efficacy of BTVA for the treatment of patients with heterogeneous upper lobe emphysema.

Detailed Description
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All subjects meeting the eligibility criteria and who provide written informed consent will be enrolled. Immediately prior to BTVA treatment, an initial bronchoscopy will be performed to evaluate the baseline condition of the airways and to confirm anatomy of the lung segments targeted for BTVA treatment. Up to 3 segments in either the right or left upper lobe will be treated with a vapor dose of 10 calories per gram of lung tissue (10 cal/g). Targeted lobe for treatment will be based on lobar disease severity.

Official Title
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US Pilot Safety and Feasibility Study of Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction in Patients With Heterogeneous Emphysema With Upper Lobe Predominance

Conditions
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Emphysema, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: BTVA System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: > 40 and ≤ 75 years old Diagnosis of heterogeneous emphysema with upper lobe predominance FEV1 < 45% predicted TLC > 100% predicted RV > 150% predicted 6-minute walk test > 140 meters mMRC ≥ 2 (mMRC) Non-smoking for 3 months Optimized medical management and completed pulmonary rehabilitation Exclusion Criteria: Known α-1-antitrypsin deficiency BMI < 15 kg/m2 or > 35 kg / m2 History of pneumothorax within previous 18 months History of heart and / or lung transplant, lung volume reduction surgery (LVRS), median sternotomy, bullectomy, and/or lobectomy Respiratory infections or recurring COPD exacerbations > 3 hospitalizations in past 12 months or active infection History of the (EF) ≤ 40%; Stroke; Unstable Myocardial Ischemia; FEV1 < 15% predicted; DLCO < 20% predicted; of pulmonary hypertension; indwelling pacemaker or implantable cardiac defibrillator (ICD); pregnancy or breastfeeding

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 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: BTVA<br> | Device: BTVA System<br>* Unilateral Bronchoscopic Thermal Vapor Ablation for Lung Volume Reduction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of adverse events (serious and non-serious) secondary to the BTVA treatment procedure from initiation of treatment through completion of the six-month follow-up period |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic evidence of lung volume reduction (assessed by study site radiologist) and CT scan (assessed by blinded radiologist at CT core lab) |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emphysema, COPD, Lung Volume Reduction, BTVA