Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction

Study Overview
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Brief Summary
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To establish and confirm the safety and clinical utility of BTVA applied unilaterally for lung volume reduction in patients with upper lobe predominate heterogeneous severe emphysema.

Detailed Description
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All subjects meeting the eligibility criteria and who provide written informed consent will be enrolled. 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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Evaluation Study of Unilateral Bronchoscopic Thermal Vapor Ablation (BTVA) in Patients With Heterogeneous Emphysema and 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; 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 |
| --- | --- | --- |
| increase in FEV1 ≥ 12% or a decrease in total St. George's Respiratory Questionnaire (SGRQ) score ≥ 4 points |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lobar volume reduction as determined by computed tomography (CT) analysis |  | 3 months | 
| Changes in pulmonary function therapy |  | 3 months | 
| Improvement in 6 minute walk distance |  | 3 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