Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01737567




Registration number
NCT01737567
Ethics application status
Date submitted
27/11/2012
Date registered
29/11/2012
Date last updated
24/07/2024

Titles & IDs
Public title
Comparison Between White Light Endoscopy and Bright Narrow Band Imaging in Diagnosis Colonic Adenomas.
Scientific title
A Randomised Comparison Between White Light Endoscopy (WLE) and Bright Narrow Band Imaging (B-NBI) in the Diagnosis of Colonic Adenomas in Asymptomatic Subjects Undergoing Screening Colonoscopy.
Secondary ID [1] 0 0
HREC2011/12/4.9 (3395)
Secondary ID [2] 0 0
HREC/11/WMEAD/223
Universal Trial Number (UTN)
Trial acronym
WLEvB-NBI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonic Adenomas 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Bright Narrow Band Imaging.
Other interventions - White Light Endoscopy

Experimental: Bright Narrow Band Imaging - Use of B-NBI to detect colonic adenomas.

Active comparator: White Light Endoscopy - Use of White Light Endoscopy to detect colonic adenomas.


Other interventions: Bright Narrow Band Imaging.
Using Bright Narrow Band Imaging to detect colonic adenomas.

Other interventions: White Light Endoscopy
Use of White Light Endoscopy to detect colonic adenomas.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Improvement in detection of colorectal adenomas.
Timepoint [1] 0 0
One year
Secondary outcome [1] 0 0
Improvement of histological prediction
Timepoint [1] 0 0
One year

Eligibility
Key inclusion criteria
* Asymptomatic subjects undergoing screening colonoscopy, age > 50, average risk subjects and, ability to provide a written consent to trial participation.
Minimum age
50 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* personal history of inflammatory bowel disease, colon adenoma or cancer
* family history of FAP or Familial nonpolyposis syndrome
* first degree relatives having diagnosed to have colorectal carcinoma
* no colonoscopy in past 5 years

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled 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
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/02/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2024
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Endoscopy Unit - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Other
Name
Professor Michael Bourke
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
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/NCT01737567