Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000505303
Ethics application status
Approved
Date submitted
16/09/2008
Date registered
30/09/2008
Date last updated
2/09/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Bronchoscopic Vapour Therapy for Emphysema (Phase 2)
Scientific title
Australia Phase 2 Safety and Efficacy Study of Bronchoscopic Thermal Vapour Ablation (BTVA) for Lung Volume Reduction in Patients with Heterogeneous Emphysema with Upper Lobe Predominance (Bilateral)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emphysema 3700 0
Condition category
Condition code
Respiratory 3864 3864 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 7 lung segments within the right and left upper lobes of the lung will be treated in one procedure. Patients in the first cohort will receive a prescribed amount of vapour (target vapour dose) delivered to each lung segment of 7.5 calories per gram of lung tissue. A second cohort of patients may be treated with a target vapour dose of 10 calories per gram of lung tissue after 3 month follow-up results are reviewed.
Intervention code [1] 3475 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4766 0
Pulmonary Function: Forced Expiratory Volume in 1 second (FEV1) > 15% or 200 mls
Timepoint [1] 4766 0
3 and 6 months following BTVA treatment
Secondary outcome [1] 8048 0
Safety: The occurrence and frequency of serious and non-serious adverse events following BTVA treatment. Examples of adverse effects include respiratory infection, pneumothorax, and increase in COPD related symptoms. Adverse effects will be assessed by the physician's evaluation, laboratory tests and chest x-rays / computerized tomography (CT).
Timepoint [1] 8048 0
Patients will be assessed each week for the first 4 weeks after treatment and again at 2, 3 and 6 months.
Secondary outcome [2] 8049 0
Evidence of lung volume reduction by radiograph and computerized tomography (CT) scan
Timepoint [2] 8049 0
3 and 6 months
Secondary outcome [3] 8050 0
Pulmonary Function: increase in Functional Residual Capacity (FRC), decrease in total lung capacity (TLC), increase in functional vital capacity (FVC), decrease in residual volume (RV), increase in carbon monoxide diffusing capacity (DLCO)
Timepoint [3] 8050 0
3 and 6 months
Secondary outcome [4] 8051 0
Improvement in exercise capacity by the 6 minute walk test (6MWT)
Timepoint [4] 8051 0
3 and 6 months
Secondary outcome [5] 8052 0
Improvement in dyspnoea score by the modified Medical Research Council scale (mMRC)
Timepoint [5] 8052 0
3 and 6 months
Secondary outcome [6] 8053 0
Improvement in quality of life as measured by the St. George Respiratory Questionnaire (SGRQ)
Timepoint [6] 8053 0
3 and 6 months

Eligibility
Key inclusion criteria
Heterogeneous emphysema with upper lobe predominance confirmed by computerized tomography (CT) and quantitative differential ventilation and perfusion scan; Able 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 or lung; previous history of unstable myocardial ischemia; FEV1 < 15%

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Subjects in two sequential cohorts will receive bilateral upper lobe treatment with BTVA. If the primary endpoint is not met with the first vapour dose cohort and the safety profile is accpetable, the target vapour dose may be increased in Cohort 2.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
15/11/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1156 0
3004
Recruitment postcode(s) [2] 1157 0
4032
Recruitment postcode(s) [3] 1177 0
5000

Funding & Sponsors
Funding source category [1] 3877 0
Commercial sector/Industry
Name [1] 3877 0
Uptake Medical Corp.
Country [1] 3877 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] 3481 0
Commercial sector/Industry
Name [1] 3481 0
Novotech Pty (Australia) Ltd
Address [1] 3481 0
Level 3 19 Harris Street Pyrmont NSW 2009
Country [1] 3481 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5928 0
The Alfred Hospital
Ethics committee address [1] 5928 0
The Alfred Hospital Ethics Committee Office
(no street number) Commercial Road Melbourne Victoria 3004
Ethics committee country [1] 5928 0
Australia
Date submitted for ethics approval [1] 5928 0
22/09/2008
Approval date [1] 5928 0
17/11/2008
Ethics approval number [1] 5928 0
Ethics committee name [2] 5929 0
The Prince Charles Hospital
Ethics committee address [2] 5929 0
Human Research Ethics Committee
Northside Health Service District
(no street number) Rode Road Chermside QLD 4032
Ethics committee country [2] 5929 0
Australia
Date submitted for ethics approval [2] 5929 0
22/09/2008
Approval date [2] 5929 0
13/11/2008
Ethics approval number [2] 5929 0
Ethics committee name [3] 5930 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [3] 5930 0
Level 3, Hanson Institute IMVS Building North Terrace
Adelaide SA 5000
Ethics committee country [3] 5930 0
Australia
Date submitted for ethics approval [3] 5930 0
17/11/2008
Approval date [3] 5930 0
Ethics approval number [3] 5930 0

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

Contacts
Principal investigator
Name 28938 0
Address 28938 0
Country 28938 0
Phone 28938 0
Fax 28938 0
Email 28938 0
Contact person for public queries
Name 12095 0
Michelle Wetherby
Address 12095 0
Uptake Medical Corp
1924 1st Ave, 3rd Floor
Seattle, WA 98101
Country 12095 0
United States of America
Phone 12095 0
1-612-564-1617
Fax 12095 0
1-763-536-5949
Email 12095 0
mwetherby@uptakemedical.com
Contact person for scientific queries
Name 3023 0
Associate Professor Gregory Snell, MD, MBBS, FRACP
Address 3023 0
Head, Lung Transplant Service (Medical)
The Alfred Hospital
PO Box 315 Prahran
Melbourne Victoria 3181
Country 3023 0
Australia
Phone 3023 0
61 3 9276 2876
Fax 3023 0
61 3 9276 3601
Email 3023 0
G.Snell@alfred.org.au

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No Supporting Document Provided



Results publications and other study-related documents

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