Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction

Not Applicable

Completed

• Conditions: Emphysema; Chronic Obstructive Pulmonary Disease
• Interventions: Device: BTVA System

• Registration Number: NCT01102712
• Lead Sponsor: Uptake Medical Corp

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-04-08
• Study First Submitted QC: 2010-04-12
• Study First Posted: 2010-04-13
• Primary Completion: 2010-12
• Study Completion: 2011-08
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-21
• Last Update Posted: 2012-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

1. Age: > 40 and ≤ 75 years old
2. Diagnosis of heterogeneous emphysema with upper lobe predominance
3. FEV1 < 45% predicted
4. TLC > 100% predicted
5. RV > 150% predicted
6. 6-minute walk test > 140 meters
7. mMRC ≥ 2 (mMRC)
8. Non-smoking for 3 months
9. Optimized medical management and completed pulmonary rehabilitation

Exclusion Criteria

1. Known α-1-antitrypsin deficiency
2. BMI < 15 kg/m2 or > 35 kg / m2
3. History of pneumothorax within previous 18 months
4. History of heart and / or lung transplant, lung volume reduction surgery (LVRS), median sternotomy, bullectomy, and/or lobectomy
5. Respiratory infections or recurring COPD exacerbations > 3 hospitalizations in past 12 months or active infection
6. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BTVA	BTVA System	-

Primary Outcome Measures

Name	Time	Method
increase in FEV1 ≥ 12% or a decrease in total St. George's Respiratory Questionnaire (SGRQ) score ≥ 4 points	6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (10)

Otto-Wagner Hospital; 🇦🇹 Wien, Austria

LKH Klagenfurt; 🇦🇹 Klagenfurt, Austria

Prince Charles Hospital; 🇦🇺 Chermside, Queensland, Australia

Abteilung fur Pneumologie; 🇩🇪 Hemer, Germany

Charite Campus Mitte; 🇩🇪 Berlin, Germany

Mater Misericordiae University Hospital; 🇮🇪 Dublin, Ireland

Klinikum Nurnberg; 🇩🇪 Nurnberg, Germany

Thoraxklinik Heidelberg; 🇩🇪 Heildelberg, Germany

The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

Zentralklinik Bad Berka; 🇩🇪 Bad Berka, Germany