Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction

Phase 1

Completed

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

• Registration Number: NCT01041586
• Lead Sponsor: Uptake Medical Corp

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-22
• Study First Submitted QC: 2009-12-30
• Study First Posted: 2009-12-31
• Primary Completion: 2011-01
• 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: 10

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; of 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
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

Name	Time	Method
Radiographic evidence of lung volume reduction (assessed by study site radiologist) and CT scan (assessed by blinded radiologist at CT core lab)	6 months

Trial Locations

Locations (3)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Swedish Hospital; 🇺🇸 Seattle, Washington, United States

John C. Lincoln Hospital; 🇺🇸 Phoenix, Arizona, United States