Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000822280
Ethics application status
Approved
Date submitted
2/09/2009
Date registered
21/09/2009
Date last updated
6/05/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Bronchoscopic Vapour Therapy for Emphysema (unilateral treatment)
Scientific title
The Effect of Unilateral Bronchoscopic Thermal Vapour Ablation (BTVA) on Pulmonary Function and Quality of Life in Patients with with Heterogeneous Emphysema and Upper Lobe Predominance
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emphysema 243621 0
Condition category
Condition code
Respiratory 239920 239920 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Vapour (steam) is infused into a targeted emphysematous lung segment for approximately 3-10 seconds. Up to 3 lung segments from one lung lobe, either the right or left upper lobes, will be treated in one procedure. Patients will receive a prescribed amount of vapour (target vapour dose) delivered to the identified lung segments of 10 calories per gram of lung tissue. The total time of the BTVA procedure is expected to be< 45 minutes.
Intervention code [1] 241210 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 240699 0
Primary Outcome 1: Pulmonary function via Forced Expiratory Volume in 1 second (FEV1) equal or greater than 12% as measured by plethysmography and spirometry
Timepoint [1] 240699 0
3 and 6 months following BTVA treatment
Primary outcome [2] 240700 0
Primary Outcome 2: Quality of Life (QOL) via St Georges Respiratory Questionnaire (SGRQ) improvement equal or greater than 4 point score reduction
Timepoint [2] 240700 0
3 and 6 months following BTVA treatment
Secondary outcome [1] 257353 0
Safety: The occurrence and frequency of serious and non-serious adverse events following BTVA treatment. Examples of adverse effects may include respiratory infection and increase in chronic obstructive pulmonary disease (COPD) related symptoms. These are measured by blood analysis and occurrence of multiple patient symptoms.
Timepoint [1] 257353 0
Patients will be assessed at Week 1, Week 2, Month 1, Month 3, Month 6 and Month 12 following BTVA treatment.
Secondary outcome [2] 257354 0
Pulmonary Function: increase in functional residual capacity (FRC); decrease in total lung capacity (TLC), decrease in residual volume (RV); increase in carbon monoxide (CO) diffusing capacity (DLCO). These outcomes will be assessed by plethysmography and spirometry.
Timepoint [2] 257354 0
3 and 6 months following BTVA treatment.
Secondary outcome [3] 257355 0
Improvement in exercise capacity as assessed by the 2-minute walk test following BTVA treatment.
Timepoint [3] 257355 0
3 and 6 months following BTVA treatment
Secondary outcome [4] 257356 0
Improvement in dyspnoea score by the modified Medical Research Council scale (mMRC) following BTVA treatment.
Timepoint [4] 257356 0
3 and 6 months following BTVA treatment.
Secondary outcome [5] 257357 0
Evidence of lung volume reduction by radiograph and/or computerized tomography (CT) scan following BTVA treatment.
Timepoint [5] 257357 0
3 and 6 months following BTVA treatment.

Eligibility
Key inclusion criteria
Heterogeneous emphysema with upper lobe predominance confirmed by computerized tomography (CT); ability to walk at least 140 meters; non-smoking for 3 months prior to study enrollment; completed pulmonary rehabilitation program
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known alpha 1 antitrypsin deficiency; previous heart or lung transplant; previous history of unstable myocardial ischemia; FEV1 < 15%, DLCO < 20%

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2048 0
4032
Recruitment postcode(s) [2] 2115 0
3004
Recruitment outside Australia
Country [1] 1971 0
Germany
State/province [1] 1971 0
Baden-Wurtenberg
Country [2] 1972 0
Austria
State/province [2] 1972 0
Vienna
Country [3] 1973 0
Germany
State/province [3] 1973 0
Berlin
Country [4] 1974 0
Germany
State/province [4] 1974 0
Bayern

Funding & Sponsors
Funding source category [1] 237569 0
Commercial sector/Industry
Name [1] 237569 0
Uptake Medical Corp.
Country [1] 237569 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Uptake Medical Corp.
Address
1924 1st Avenue, 3rd Floor
Seattle, Washington
USA 98101
Country
United States of America
Secondary sponsor category [1] 237044 0
Commercial sector/Industry
Name [1] 237044 0
Novotech Pty (Australia) Ltd
Address [1] 237044 0
Level 3 19 Harris Street Pyrmont NSW 2009
Country [1] 237044 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243697 0
Freiburger Ethik-kommission International
Ethics committee address [1] 243697 0
Mozartstrasse
79104 Freiburg, Germany
Ethics committee country [1] 243697 0
Germany
Date submitted for ethics approval [1] 243697 0
Approval date [1] 243697 0
03/08/2009
Ethics approval number [1] 243697 0

Summary
Brief summary
The primary purpose of this study is to evaluate the safety and effectiveness of a unilateral application of bronchoscopic thermal vapour ablation for improvement in function and demonstrate reduction of lung volume in patients diagnosed with heterogeneous upper lobe emphysema.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30110 0
Address 30110 0
Country 30110 0
Phone 30110 0
Fax 30110 0
Email 30110 0
Contact person for public queries
Name 13357 0
Mike Numamoto
Address 13357 0
Uptake Medical Corp
1924 1st Ave, 3rd Flr
Seattle, WA 98101
Country 13357 0
United States of America
Phone 13357 0
+1 949 2755172
Fax 13357 0
Email 13357 0
[email protected]
Contact person for scientific queries
Name 4285 0
Associate Professor Gregory Snell, MD, MBBS, FRACP
Address 4285 0
Head, Lung Transplant Service (Medical)
The Alfred Hospital
PO Box 315 Prahran
Melbourne Victoria 3181
Country 4285 0
Australia
Phone 4285 0
+61 3 92762876
Fax 4285 0
+61 3 92763601
Email 4285 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.