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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01102712
Other study ID # Vapor-OUS
Secondary ID
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


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
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