The Utility of Cap Colonoscopy in Increasing Adenoma Detection Rate
|ClinicalTrials.gov Identifier: NCT01601431|
Recruitment Status : Terminated (Study was inactivated by the IRB since PI left institution.)
First Posted : May 18, 2012
Results First Posted : June 7, 2018
Last Update Posted : June 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Adenoma||Device: Cap Assisted Colonoscopy Device: Conventional colonoscopy||Not Applicable|
This is a prospective, randomized trial comparing the adenoma detection rate between Hispanic patients undergoing a screening colonoscopy with a conventional colonoscope or with a cap-assisted colonoscopy. The aims of the study are:
- Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap.
- Compare the overall polyp detection rate between Hispanic patients undergoing a screening colonoscopy with and without cap.
- Compare the cecal intubation rate and cecal intubation time between standard colonoscopy and cap assisted colonoscopy.
- Compare the complication rate between standard colonoscopy and cap assisted colonoscopy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||440 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Utility of Cap Colonoscopy in Increasing Adenoma Detection Rate|
|Actual Study Start Date :||March 29, 2012|
|Actual Primary Completion Date :||February 2, 2015|
|Actual Study Completion Date :||February 2, 2015|
Experimental: Cap Assisted Colonoscopy
Cap Assisted Colonoscopy uses a Cap which is a transparent hood which is attached to the distal end of the colonscope and allows depressing the colon folds in order to visualize hidden polyps behind the folds.
Device: Cap Assisted Colonoscopy
Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate
Active Comparator: Conventional colonoscopy
A conventional colonoscopy does not use a Cap in order to perform the procedure
Device: Conventional colonoscopy
Regular colonoscopy as per standard clinical guidelines
- ADR Differences in Hispanic Patients Undergoing a Screening Colonoscopy With and Without Cap. [ Time Frame: 1 year ]1. Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01601431
|United States, Texas|
|Texas Tech University Health Sciences Center at El Paso|
|El Paso, Texas, United States, 79905|
|Principal Investigator:||Mohamed O Othman, MD||Texas Tech University Health Sciences Center|