Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction

Chronic Obstructive Pulmonary Disease Clinical Trial

— BTVA  

Official title:

Evaluation Study of Unilateral Bronchoscopic Thermal Vapor Ablation (BTVA) in Patients With Heterogeneous Emphysema and Upper Lobe Predominance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01102712
• Other study ID #: Vapor-OUS
• Status: Completed
• Phase: N/A
• First received: April 8, 2010
• Last updated: February 21, 2012
• Start date: November 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: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 2011
• Est. primary completion date: December 2010
• 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; 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
Australia	Prince Charles Hospital	Chermside	Queensland
Australia	The Alfred Hospital	Melbourne	Victoria
Austria	LKH Klagenfurt	Klagenfurt
Austria	Otto-Wagner Hospital	Wien
Germany	Zentralklinik Bad Berka	Bad Berka
Germany	Charite Campus Mitte	Berlin
Germany	Thoraxklinik Heidelberg	Heildelberg
Germany	Abteilung fur Pneumologie	Hemer
Germany	Klinikum Nurnberg	Nurnberg
Ireland	Mater Misericordiae University Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
Uptake Medical Corp

Countries where clinical trial is conducted

Australia,  Austria,  Germany,  Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	increase in FEV1 = 12% or a decrease in total St. George's Respiratory Questionnaire (SGRQ) score = 4 points		6 months	No
Secondary	Lobar volume reduction as determined by computed tomography (CT) analysis		3 months	No
Secondary	Changes in pulmonary function therapy		3 months
Secondary	Improvement in 6 minute walk distance		3 months