Trial Outcomes & Findings for The Utility of Cap Colonoscopy in Increasing Adenoma Detection Rate (NCT NCT01601431)

NCT ID: NCT01601431

Last Updated: 2018-06-07

Results Overview

1\. Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 440 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2018-06-07

Participant Flow

Participant milestones

Measure	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. Cap Assisted Colonoscopy: Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate	Conventional Colonoscopy A conventional colonoscopy does not use a Cap in order to perform the procedure
Overall Study STARTED	223	217
Overall Study COMPLETED	211	214
Overall Study NOT COMPLETED	12	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Utility of Cap Colonoscopy in Increasing Adenoma Detection Rate

Baseline characteristics by cohort

Measure	Cap Assisted Colonoscopy n=223 Participants 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. Cap Assisted Colonoscopy: Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate	Conventional Colonoscopy n=217 Participants A conventional colonoscopy does not use a Cap in order to perform the procedure Cap Assisted Colonoscopy: Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate Conventional colonoscopy: Regular colonoscopy as per standard clinical guidelines	Total n=440 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	220 Participants n=5 Participants	212 Participants n=7 Participants	432 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Age, Continuous	59.48 years STANDARD_DEVIATION 7.28 • n=5 Participants	60.08 years STANDARD_DEVIATION 7.26 • n=7 Participants	60 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	146 Participants n=5 Participants	155 Participants n=7 Participants	301 Participants n=5 Participants
Sex: Female, Male Male	77 Participants n=5 Participants	62 Participants n=7 Participants	139 Participants n=5 Participants
Adenoma Detection Rate	66 Participants n=5 Participants	69 Participants n=7 Participants	135 Participants n=5 Participants
Polyp detection rate	87 Participants n=5 Participants	92 Participants n=7 Participants	179 Participants n=5 Participants
Advanced adenoma detection rate	21 Participants n=5 Participants	10 Participants n=7 Participants	31 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

1. Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap.

Outcome measures

Measure	Cap Assisted Colonoscopy n=211 Participants 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. Cap Assisted Colonoscopy: Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate	Conventional Colonoscopy n=214 Participants A conventional colonoscopy does not use a Cap in order to perform the procedure Cap Assisted Colonoscopy: Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate Conventional colonoscopy: Regular colonoscopy as per standard clinical guidelines
ADR Differences in Hispanic Patients Undergoing a Screening Colonoscopy With and Without Cap.	66 Participants	69 Participants

Adverse Events

Cap Assisted Colonoscopy

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Conventional Colonoscopy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cap Assisted Colonoscopy n=211 participants at risk 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. Cap Assisted Colonoscopy: Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate	Conventional Colonoscopy n=214 participants at risk A conventional colonoscopy does not use a Cap in order to perform the procedure Cap Assisted Colonoscopy: Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate Conventional colonoscopy: Regular colonoscopy as per standard clinical guidelines
Gastrointestinal disorders Perforation	0.47% 1/211 • Number of events 1	0.00% 0/214

Other adverse events

Adverse event data not reported

Additional Information

Mohamed Othman, M.D.

Baylor College of Medicine

Phone: 713 798 0947

Email: mohamed.othman@bcm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place