Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000001594
Ethics application status
Approved
Date submitted
3/01/2006
Date registered
3/01/2006
Date last updated
19/01/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase 1 assessment of a diagnostic trocar system for the detection of bowel damage at laparoscopy
Scientific title
Phase 1 assessment of a diagnostic trocar system for the detection of bowel damage at laparoscopy
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bowel damage at laparoscopy 962 0
Condition category
Condition code
Other 1032 1032 0 0
Bowel - Anal
Other 1033 1033 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Other 1034 1034 0 0
Bowel - Small bowel (duodenum and ileum

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Assessment of analyte from trocars used at laparoscopy
Intervention code [1] 819 0
None
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1384 0
Assessment of bowel damage at laparoscopy
Timepoint [1] 1384 0
Secondary outcome [1] 2448 0
Absence of bowel damage at laparoscopy.
Timepoint [1] 2448 0

Eligibility
Key inclusion criteria
All patients undergoing laparoscopy
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Diagnosis
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 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1134 0
Self funded/Unfunded
Name [1] 1134 0
Michael Cooper
Country [1] 1134 0
Primary sponsor type
Government body
Name
Sydney South West Area Health Service
Address
Country
Australia
Secondary sponsor category [1] 991 0
Individual
Name [1] 991 0
Michael Cooper
Address [1] 991 0
Country [1] 991 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35558 0
Address 35558 0
Country 35558 0
Phone 35558 0
Fax 35558 0
Email 35558 0
Contact person for public queries
Name 10008 0
Michael Cooper
Address 10008 0
Level 7
187 Macquarie St
Sydney NSW 2000
Country 10008 0
Australia
Phone 10008 0
+61 2 92333546
Fax 10008 0
+61 2 92328270
Email 10008 0
michael@mjwcooper.com.au
Contact person for scientific queries
Name 936 0
Michael Cooper
Address 936 0
Level 7
187 Macquarie St
Sydney NSW 2000
Country 936 0
Australia
Phone 936 0
+61 2 92333546
Fax 936 0
+61 2 92328270
Email 936 0
michael@mjwcooper.com.au

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.