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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01102712




Registration number
NCT01102712
Ethics application status
Date submitted
8/04/2010
Date registered
13/04/2010
Date last updated
23/02/2012

Titles & IDs
Public title
Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction
Scientific title
Evaluation Study of Unilateral Bronchoscopic Thermal Vapor Ablation (BTVA) in Patients With Heterogeneous Emphysema and Upper Lobe Predominance
Secondary ID [1] 0 0
Vapor-OUS
Universal Trial Number (UTN)
Trial acronym
BTVA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emphysema 0 0
Chronic Obstructive Pulmonary Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - BTVA System

Experimental: BTVA -


Treatment: Devices: BTVA System
Unilateral Bronchoscopic Thermal Vapor Ablation for Lung Volume Reduction
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
increase in FEV1 = 12% or a decrease in total St. George's Respiratory Questionnaire (SGRQ) score = 4 points
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Lobar volume reduction as determined by computed tomography (CT) analysis
Timepoint [1] 0 0
3 months
Secondary outcome [2] 0 0
Changes in pulmonary function therapy
Timepoint [2] 0 0
3 months
Secondary outcome [3] 0 0
Improvement in 6 minute walk distance
Timepoint [3] 0 0
3 months

Eligibility
Key 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
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2011
Sample size
Target
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Prince Charles Hospital - Chermside
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
4032 - Chermside
Recruitment postcode(s) [2] 0 0
3181 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Klagenfurt
Country [2] 0 0
Austria
State/province [2] 0 0
Wien
Country [3] 0 0
Germany
State/province [3] 0 0
Bad Berka
Country [4] 0 0
Germany
State/province [4] 0 0
Berlin
Country [5] 0 0
Germany
State/province [5] 0 0
Heildelberg
Country [6] 0 0
Germany
State/province [6] 0 0
Hemer
Country [7] 0 0
Germany
State/province [7] 0 0
Nurnberg
Country [8] 0 0
Ireland
State/province [8] 0 0
Dublin

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Uptake Medical Corp
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01102712
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01102712