Will Cap-Assisted Colonoscopy Improve Performance of Colonoscopy: A Randomized Clinical Trial (CAC)
|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 evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01126632|
Recruitment Status : Withdrawn (Caps became unavailable by manufacturer)
First Posted : May 20, 2010
Last Update Posted : January 28, 2016
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Will Cap-Assisted Colonoscopy Improve Performance of Colonoscopy: A Randomized Clinical Trial|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Cap Assisted Colonoscopy
Patients receiving colonoscopies where scope is fitted with cap
Patients receiving standard colonoscopy without the cap on the scope
- cap-assisted colonoscopy compared visibility with standard colonoscopy [ Time Frame: 4 months ]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.
- Polyp detection rate [ Time Frame: 4 months ]Number of Polyps detected per procedure using the cap. To see if it is more visible.
- Adenoma Detection [ Time Frame: 4 months ]number of adenomatous polyps detected per procedure. To see if it is more visible using the cap as to not using the cap.
- Advanced lesion detection rate [ Time Frame: 4 months ](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.
- Cecal Intubation Rate [ Time Frame: 4 months ]Time to cecum
- Total time for colonoscopy [ Time Frame: 4 months ]
- Complication Rate [ Time Frame: 4 months ]Amount of complications during colonoscopies
- Procedure indication [ Time Frame: 4 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01126632
|Canada, Nova Scotia|
|Capital District Health Authority|
|Halifax, Nova Scotia, Canada, B3H 2Y9|
|Principal Investigator:||Donald G MacIntosh, MD||Nova Scotia Health Authority|