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NCT01126632 Clinical Trial

Will Cap-Assisted Colonoscopy Improve Performance of Colonoscopy: A Randomized Clinical Trial

Colonoscopy Clinical Trial

— CAC  

Official title:
Will Cap-Assisted Colonoscopy Improve Performance of Colonoscopy: A Randomized Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01126632
Other study ID # CAC Study
Secondary ID
Status Withdrawn
Phase N/A
First received May 15, 2010
Last updated January 27, 2016
Start date June 2010
Est. completion date January 2012

Study information
Verified date January 2016
Source Nova Scotia Health Authority
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Observational

Clinical Trial Summary

Observing the effects of an Olympus cap on the visibility and in adenoma detection during colonoscopy.

Description:

To see if Colonoscopy with the CAP is able to give more visibility and to see if detection rate for adenomas, polyps are easier to detect.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients already booked for a colonoscopy

Exclusion Criteria:

- History of Colorectal Cancer

- Severe colitis

- Cancer

- poor bowel prep

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Canada Capital District Health Authority Halifax Nova Scotia

Sponsors (1)
Lead Sponsor Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Lee YT, Lai LH, Hui AJ, Wong VW, Ching JY, Wong GL, Wu JC, Chan HL, Leung WK, Lau JY, Sung JJ, Chan FK. Efficacy of cap-assisted colonoscopy in comparison with regular colonoscopy: a randomized controlled trial. Am J Gastroenterol. 2009 Jan;104(1):41-6. d — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary cap-assisted colonoscopy compared visibility with standard colonoscopy Propose to perform a randomized controlled trial comparing cap-assisted colonoscopy with the standard colonoscopy to assess visibility. To see if it is easier to detect polyps, adenomas with the cap than without. This is standard procedure. Just comparing if it is better to use the cap during colonoscopy. 4 months No
Secondary Polyp detection rate Number of Polyps detected per procedure using the cap. To see if it is more visible. 4 months No
Secondary Adenoma Detection number of adenomatous polyps detected per procedure. To see if it is more visible using the cap as to not using the cap. 4 months No
Secondary Advanced lesion detection rate (number of advanced lesions per procedure) defined as lesions with high-grade dysplasia, greater than 1 cm. size. To see if it is more visible using the cap as to not using the cap. 4 months No
Secondary Cecal Intubation Rate Time to cecum 4 months No
Secondary Total time for colonoscopy 4 months No
Secondary Complication Rate Amount of complications during colonoscopies 4 months No
Secondary Procedure indication 4 months No
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