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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00207337




Registration number
NCT00207337
Ethics application status
Date submitted
12/09/2005
Date registered
21/09/2005
Date last updated
23/01/2008

Titles & IDs
Public title
Exhale (R) Stent for Emphysema
Scientific title
A Prospective Feasibility Study to Evaluate the Safety and Performance of the Exhale(R) Drug-Eluting Stent System in Patients With Emphysema
Secondary ID [1] 0 0
0304-28
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emphysema 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Procedural and technical success - operatively
Timepoint [1] 0 0
Primary outcome [2] 0 0
Decrease in residual volume > 300mL from baseline
Timepoint [2] 0 0
Primary outcome [3] 0 0
Safety
Timepoint [3] 0 0
Secondary outcome [1] 0 0
Dyspnea scoring
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Pulmonary function measures
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Exercise tolerance
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Quality of life measures
Timepoint [4] 0 0

Eligibility
Key inclusion criteria
1. High resolution computed tomography (CT) scan evidence of bilateral emphysema
2. Residual volume (RV) = 220% predicted.
3. Total lung capacity (TLC) = 133% of predicted value.
4. Forced expiratory volume (FEV1) < 40% of predicted or FEV1 < 1 liter.
5. Marked dyspnea, scoring = 2 on the modified Medical Research Council scale of 0-4.
6. Patient has undergone pulmonary rehabilitation of 16 - 20 sessions.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. FEV1 > 20%
2. Diffusing capacity for carbon monoxide (DLco) < 15% of predicted.
3. Respiratory infection requiring > 3 hospitalizations in past year
4. Inability to walk > 140 meters in 6 minutes
5. Giant bulla > 1/3 of one lung's volume
6. Previous lung volume reduction surgery (LVRS) or lobectomy.

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
Phase
Phase 2
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
1/07/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2006
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Rode Road, Chermside
Recruitment hospital [2] 0 0
The Alfred Hospital - Prahran
Recruitment hospital [3] 0 0
Concord Repatriation General Hospital - Burwood
Recruitment postcode(s) [1] 0 0
4032 - Rode Road, Chermside
Recruitment postcode(s) [2] 0 0
3181 - Prahran
Recruitment postcode(s) [3] 0 0
2134 - Burwood
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Porto Alegre
Country [2] 0 0
Germany
State/province [2] 0 0
Saarland
Country [3] 0 0
Germany
State/province [3] 0 0
Hannover

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Broncus Technologies
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gregory I. Snell, MD
Address 0 0
The Alfred
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

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00207337