At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prospective RCT of Water Exchange (WE) vs. WE Plus Cap-Assisted Colonoscopy
In Brief
A clinical study evaluating Control and Study method for Unsedated Colonoscopy and 3 related conditions. Completed, enrolled 280 participants across 3 sites.
Detailed Summary
This is a study to compare two different, but normally, used methods of colonoscopy in patients undergoing colonoscopy without sedation. There will be two arms in this study: WE (water exchange) control, and WE (water exchange) plus cap (placed at tip of the colonoscope). The patient will prepare himself/herself for the colonoscopy as per normal instructions and he/she will be given the information for the study at that time so that he/she can make a decision to participate in the study. The control method will use water instead of air during insertion of the colonoscope. The study method will use a cap that will fit onto the end of the colonoscope plus water during insertion of the colonoscope. This study will assess if the study method is less painful than the control method.
Study Details
Timeline
Interventions
Unsedated colonoscopy with water exchange (WE) where the residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water is removed predominantly during insertion.
Unsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope.