Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction

Chronic Obstructive Pulmonary Disease Clinical Trial

— BTVA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01041586
• Other study ID #: VAPOR-US
• Status: Completed
• Phase: Phase 1
• First received: December 22, 2009
• Last updated: February 21, 2012
• Start date: December 2009
• Est. completion date: August 2011

Study information

• Verified date: February 2012
• Source: Uptake Medical Corp
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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 a-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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Emphysema
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Emphysema

Intervention

Device:
• BTVA System
Unilateral Bronchoscopic Thermal Vapor Ablation for Lung Volume Reduction

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa
United States	John C. Lincoln Hospital	Phoenix	Arizona
United States	Swedish Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Uptake Medical Corp

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Radiographic evidence of lung volume reduction (assessed by study site radiologist) and CT scan (assessed by blinded radiologist at CT core lab)		6 months	No