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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01041586
Other study ID # VAPOR-US
Secondary ID
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


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
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