Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction (BTVA)
Primary Purpose
Emphysema, Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
BTVA System
Sponsored by
About this trial
This is an interventional treatment trial for Emphysema focused on measuring Emphysema, COPD, Lung Volume Reduction, BTVA
Eligibility Criteria
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
Sites / Locations
- Prince Charles Hospital
- The Alfred Hospital
- LKH Klagenfurt
- Otto-Wagner Hospital
- Zentralklinik Bad Berka
- Charite Campus Mitte
- Thoraxklinik Heidelberg
- Abteilung fur Pneumologie
- Klinikum Nurnberg
- Mater Misericordiae University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BTVA
Arm Description
Outcomes
Primary Outcome Measures
increase in FEV1 ≥ 12% or a decrease in total St. George's Respiratory Questionnaire (SGRQ) score ≥ 4 points
Secondary Outcome Measures
Lobar volume reduction as determined by computed tomography (CT) analysis
Changes in pulmonary function therapy
Improvement in 6 minute walk distance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01102712
Brief Title
Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction
Acronym
BTVA
Official Title
Evaluation Study of Unilateral Bronchoscopic Thermal Vapor Ablation (BTVA) in Patients With Heterogeneous Emphysema and Upper Lobe Predominance
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uptake Medical Corp
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emphysema, Chronic Obstructive Pulmonary Disease
Keywords
Emphysema, COPD, Lung Volume Reduction, BTVA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BTVA
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
BTVA System
Intervention Description
Unilateral Bronchoscopic Thermal Vapor Ablation for Lung Volume Reduction
Primary Outcome Measure Information:
Title
increase in FEV1 ≥ 12% or a decrease in total St. George's Respiratory Questionnaire (SGRQ) score ≥ 4 points
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Lobar volume reduction as determined by computed tomography (CT) analysis
Time Frame
3 months
Title
Changes in pulmonary function therapy
Time Frame
3 months
Title
Improvement in 6 minute walk distance
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Prince Charles Hospital
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
LKH Klagenfurt
City
Klagenfurt
ZIP/Postal Code
9020
Country
Austria
Facility Name
Otto-Wagner Hospital
City
Wien
ZIP/Postal Code
1140
Country
Austria
Facility Name
Zentralklinik Bad Berka
City
Bad Berka
ZIP/Postal Code
99437
Country
Germany
Facility Name
Charite Campus Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Thoraxklinik Heidelberg
City
Heildelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Abteilung fur Pneumologie
City
Hemer
ZIP/Postal Code
58675
Country
Germany
Facility Name
Klinikum Nurnberg
City
Nurnberg
ZIP/Postal Code
90419
Country
Germany
Facility Name
Mater Misericordiae University Hospital
City
Dublin
ZIP/Postal Code
7
Country
Ireland
12. IPD Sharing Statement
Citations:
PubMed Identifier
22927751
Citation
Herth FJ, Ernst A, Baker KM, Egan JJ, Gotfried MH, Hopkins P, Stanzel F, Valipour A, Wagner M, Witt C, Kesten S, Snell G. Characterization of outcomes 1 year after endoscopic thermal vapor ablation for patients with heterogeneous emphysema. Int J Chron Obstruct Pulmon Dis. 2012;7:397-405. doi: 10.2147/COPD.S31082. Epub 2012 Jul 18.
Results Reference
derived
PubMed Identifier
22075481
Citation
Snell G, Herth FJ, Hopkins P, Baker KM, Witt C, Gotfried MH, Valipour A, Wagner M, Stanzel F, Egan JJ, Kesten S, Ernst A. Bronchoscopic thermal vapour ablation therapy in the management of heterogeneous emphysema. Eur Respir J. 2012 Jun;39(6):1326-33. doi: 10.1183/09031936.00092411. Epub 2011 Nov 10.
Results Reference
derived
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Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction
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