Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction

Sponsor

Uptake Medical Corp (Industry)

Overall Status

Completed

CT.gov ID

NCT01102712

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

3.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Emphysema Chronic Obstructive Pulmonary Disease	Device: BTVA System	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2009

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BTVA	Device: BTVA System Unilateral Bronchoscopic Thermal Vapor Ablation for Lung Volume Reduction

Arm

Intervention/Treatment

Experimental: BTVA

Device: BTVA System

Unilateral Bronchoscopic Thermal Vapor Ablation for Lung Volume Reduction

Outcome Measures

Primary Outcome Measures

increase in FEV1 ≥ 12% or a decrease in total St. George's Respiratory Questionnaire (SGRQ) score ≥ 4 points [6 months]

Secondary Outcome Measures

Lobar volume reduction as determined by computed tomography (CT) analysis [3 months]
Changes in pulmonary function therapy [3 months]
Improvement in 6 minute walk distance [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age: > 40 and ≤ 75 years old
Diagnosis of heterogeneous emphysema with upper lobe predominance
FEV1 < 45% predicted
TLC > 100% predicted
RV > 150% predicted
6-minute walk test > 140 meters
mMRC ≥ 2 (mMRC)
Non-smoking for 3 months
Optimized medical management and completed pulmonary rehabilitation

Exclusion Criteria:

Known α-1-antitrypsin deficiency
BMI < 15 kg/m2 or > 35 kg / m2
History of pneumothorax within previous 18 months
History of heart and / or lung transplant, lung volume reduction surgery (LVRS), median sternotomy, bullectomy, and/or lobectomy
Respiratory infections or recurring COPD exacerbations > 3 hospitalizations in past 12 months or active infection
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Prince Charles Hospital	Chermside	Queensland	Australia	4032
2	The Alfred Hospital	Melbourne	Victoria	Australia	3181
3	LKH Klagenfurt	Klagenfurt		Austria	9020
4	Otto-Wagner Hospital	Wien		Austria	1140
5	Zentralklinik Bad Berka	Bad Berka		Germany	99437
6	Charite Campus Mitte	Berlin		Germany	10117
7	Thoraxklinik Heidelberg	Heildelberg		Germany	69126
8	Abteilung fur Pneumologie	Hemer		Germany	58675
9	Klinikum Nurnberg	Nurnberg		Germany	90419
10	Mater Misericordiae University Hospital	Dublin		Ireland	7