Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000602426
Ethics application status
Approved
Date submitted
20/10/2007
Date registered
22/11/2007
Date last updated
4/02/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Bronchoscopic Vapour Therapy for Emphysema
Scientific title
A First-in-Man Safety & Feasibility Study of Bronchoscopic Thermal Vapour Ablation (BTVA) for Lung Volume Reduction in Patients with Heterogeneous Upper Lobe Emphysema (Phase 1)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emphysema 2486 0
Condition category
Condition code
Respiratory 2586 2586 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 4-8 seconds. No more than 3 segments within 1 lobe of a lung will be treated. The 3 segments will be treated in one procedure, with a waiting time of at least 4 minutes between each vapour treatment. The total time of the BTVA procedure is expected to be 1.5 hours.
Intervention code [1] 2216 0
Treatment: Devices
Comparator / control treatment
Not Applicable - single group trial
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3496 0
All serious and non-serious events secondary to the BTVA procedure
Timepoint [1] 3496 0
Initiation through 6 months after intervention
Secondary outcome [1] 5832 0
Pulmonary Function Status as measured by Forced Expiratory Volume in 1 second (FEV1) and Diffusing Capacity of Lung - carbon monoxide (DLCO).
Timepoint [1] 5832 0
3 and 6 months after intervention
Secondary outcome [2] 5833 0
Exercise capacity (6 minute walk test)
Timepoint [2] 5833 0
3 and 6 months after intervention
Secondary outcome [3] 5834 0
Quality of Life (St. George Respiratory Questionnaire)
Timepoint [3] 5834 0
3 and 6 months after intervention

Eligibility
Key inclusion criteria
Patients diagnosed with heterogeneous emphysema with upper lobe predominance as evidence by Computed Tomography (CT) imaging

FEV1 > 45% predicted; Total Lung Capacity (TLC) / 100% predicted; Residual Volume (RV) > 150% predicted

Exercise Capacity: Ability to walk > 140 metres in 6 minutes after completing a pulmonary rehabilitation program

Non-smoking for 4 months prior to study enrollment

Dyspnea scoring > or = 2 (of 4)
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients diagnosed with homogeneous emphysema or heterogeneous emphysema with lower lobe predominance

Known alpha-1 antityrpsin deficiency

Body Mass Index (BMI) < 15kg/m2 or > 35 kg/m2 - body mass index is the relationship between weight and height that is associated with body fat and health risk

Clinically significant asthma, chronic bronchitis or bronchiectasis

Patients with heart/lung transplant or prior lung volume reduction surgery

Patients with significant pulmonary hypertension, heart disease or history of stroke

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
Single group
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/10/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 302 0
4032
Recruitment postcode(s) [2] 303 0
3181
Recruitment postcode(s) [3] 304 0
5000

Funding & Sponsors
Funding source category [1] 2741 0
Commercial sector/Industry
Name [1] 2741 0
Uptake Medical Corp
Country [1] 2741 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Uptake Medical Corp.
Address
1942 1st Avenue
3rd FL
Seattle Washinton 98101
Country
United States of America
Secondary sponsor category [1] 2476 0
Other
Name [1] 2476 0
Novotech (Australia) Pty Limited
Address [1] 2476 0
Level 3
19 Harris Street
Pyrmont NSW 2009
Country [1] 2476 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4658 0
The Prince Charles Hospital
Ethics committee address [1] 4658 0
Human Research Ethics Committee
The Prince Charles Hospital
Northside Health Service District
Rode Road
Chermside QLD 4032
Ethics committee country [1] 4658 0
Australia
Date submitted for ethics approval [1] 4658 0
31/08/2007
Approval date [1] 4658 0
14/09/2007
Ethics approval number [1] 4658 0
EC2787
Ethics committee name [2] 4742 0
The Alfred Hospital
Ethics committee address [2] 4742 0
The Alfred Hospital Ethics Committee Office
Commercial Road
Melbourne Victoria 3004
Ethics committee country [2] 4742 0
Australia
Date submitted for ethics approval [2] 4742 0
17/09/2007
Approval date [2] 4742 0
12/11/2007
Ethics approval number [2] 4742 0
ABN 27 318 956 319

Summary
Brief summary
The primary purpose of this study is to established the side effect and benefit profile of BTVA in patients with heterogeneous upper lobe emphysema. The results will help to support subsequent clinical trials in a larger patient sample.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28135 0
Address 28135 0
Country 28135 0
Phone 28135 0
Fax 28135 0
Email 28135 0
Contact person for public queries
Name 11292 0
Pamela P. Simons, BS, RT(r)
Address 11292 0
Vice-President
Clinical & Regulatory Affairs
Clinical & Regulatory Affairs Office
Uptake Medical Corp.
9688 63rd Avenue
Maple Grove
Minnesota 55369
Country 11292 0
United States of America
Phone 11292 0
+1 612 5641612
Fax 11292 0
+1 763 5365949
Email 11292 0
[email protected]
Contact person for scientific queries
Name 2220 0
Peter Hopkins, MD, MBBS, FRACP
Address 2220 0
Consultant Tranplant & Thoracic Physician
Prince Charles Hospital
Private Practice Clinic
Rode Road
Chermisde QLD 4032
Country 2220 0
Australia
Phone 2220 0
+61 7 31396486
Fax 2220 0
Email 2220 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.