Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000291684
Ethics application status
Approved
Date submitted
26/08/2005
Date registered
5/09/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective multi-centre evaluation of clinical and economic outcomes of Double-balloon enteroscopy in patients with identified small bowel pathology.
Scientific title
A prospective multi-centre evaluation of clinical and economic outcomes of Double-balloon enteroscopy in patients with identified small bowel pathology.
Secondary ID [1] 136 0
Double-01
Universal Trial Number (UTN)
Trial acronym
Double-01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Identified pathology of the small bowel 379 0
Condition category
Condition code
Surgery 449 449 0 0
Other surgery
Oral and Gastrointestinal 450 450 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Double-balloon enteroscopy will be performed on patients with small bowel pathology diagnosed by any imaging modality. Double-balloon enteroscopy is an endoscopic procedure with a median duration of 90 minutes.
Intervention code [1] 276 0
Treatment: Devices
Comparator / control treatment
Control group
Historical

Outcomes
Primary outcome [1] 511 0
Yield of accessing and histological confirmation of small bowel pathology.
Timepoint [1] 511 0
Secondary outcome [1] 1097 0
Change in clinical management due to the use of double-balloon enteroscopy and the impact of these changes on healthcare costs.
Timepoint [1] 1097 0

Eligibility
Key inclusion criteria
Identified small bowel pathology beyond the reach of standard endoscopic equipment.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy, unfit for surgery, previous major abdominal surgery.

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 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
125
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 499 0
Self funded/Unfunded
Name [1] 499 0
Investigator initiated
Country [1] 499 0
Primary sponsor type
Individual
Name
Dr Warwick Selby
Address
Country
Secondary sponsor category [1] 408 0
Individual
Name [1] 408 0
Investiagtor initiated
Address [1] 408 0
Country [1] 408 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1478 0
Royal Brisbane and Woems Hospital
Ethics committee address [1] 1478 0
Ethics committee country [1] 1478 0
Australia
Date submitted for ethics approval [1] 1478 0
Approval date [1] 1478 0
Ethics approval number [1] 1478 0
Ethics committee name [2] 1479 0
Royal Prince Alfred Hospital Sydney
Ethics committee address [2] 1479 0
Ethics committee country [2] 1479 0
Australia
Date submitted for ethics approval [2] 1479 0
Approval date [2] 1479 0
Ethics approval number [2] 1479 0
Ethics committee name [3] 1480 0
St Vincents Hospital Melbourne
Ethics committee address [3] 1480 0
Ethics committee country [3] 1480 0
Australia
Date submitted for ethics approval [3] 1480 0
Approval date [3] 1480 0
Ethics approval number [3] 1480 0
Ethics committee name [4] 1481 0
Ethics pending at Bankstown-Lidcombe Hospital and Royal Melbourne Hospital
Ethics committee address [4] 1481 0
Ethics committee country [4] 1481 0
Australia
Date submitted for ethics approval [4] 1481 0
Approval date [4] 1481 0
Ethics approval number [4] 1481 0

Summary
Brief summary
Evaluation of clinicaL and economic impact of double-balloon enteraoscpy in patients with identified small bowel pathology
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35567 0
Address 35567 0
Country 35567 0
Phone 35567 0
Fax 35567 0
Email 35567 0
Contact person for public queries
Name 9465 0
Dr Elizabeth Harris
Address 9465 0
1 Yallambee Road
Riverview NSW 2066
Country 9465 0
Australia
Phone 9465 0
+61 2 94284928
Fax 9465 0
+61 2 94283262
Email 9465 0
[email protected]
Contact person for scientific queries
Name 393 0
Dr Elizabeth Harris
Address 393 0
1 Yallambee Road
Riverview NSW 2066
Country 393 0
Australia
Phone 393 0
+61 2 94284928
Fax 393 0
+61 2 94283262
Email 393 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.