The Utility of Cap Colonoscopy in Increasing Adenoma Detection Rate
|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: 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.
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): 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|