Three Arm Rand Trial of HD Light vs Reveal® Cap vs Endocuff Cap for Detection of Colorectal Adenomas (TRACE)

(TRACE Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Prateek Sharma, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Midwest Biomedical Research Foundation

No Placebo Group

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

Protocol Title: Three Arm Prospective Randomized controlled trial of High-Definition White-light colonoscopy versus High-Definition White-light colonoscopy with Reveal® Distal Attachment Cap versus High-Definition White-light colonoscopy with Endocuff Vision for the detection of colorectal adenomas Hypothesis: Detection rate of adenomas in patients will be higher in procedures performed with High-Definition White-light (HDWL) colonoscopy with Reveal® distal attachment cap and HDWL colonoscopy with Endocuff Vision compared to HDWL colonoscopes alone Design: Multicenter, Prospective, randomized controlled study Primary Aim: To compare the proportion of subjects with at least one adenoma detected during HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision. Secondary Aims: To compare the number of adenomas detected per subject with HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision. To compare the detection rates for polyp subtypes (including advanced adenomas, serrated polyps, right sided adenomas, etc.), cecal intubation rate, insertion time, withdrawal time, and complications of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.

Research Team

Prateek Sharma, MD

Principal Investigator

Kansas City VA Hospital

Eligibility Criteria

Inclusion Criteria

Referral for screening or surveillance colonoscopy

Ability to provide informed consent

Treatment Details

Interventions

• Colonoscopy (Procedure)
• Distal Cap (Device)
• Endocuff (Device)

Participant Groups

Group I: High-Definition White-light Colonoscopy Active Control 1 Intervention

Using an instrument called colonoscope which is used to detect colonic polyps

Group II: High-Definition White-light Colonoscopy With Reveal® Active Control 2 Interventions

Using an instrument called cap at end of colonoscope which is used to straighten colon folds

Group III: High-Definition White-light Colonoscopy With Endocuff Vision Active Control 2 Interventions

Using an instrument called Endocuff at end of colonoscope which is used to straighten colon folds

Colonoscopy is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as Colonoscopy for:

• Colorectal cancer screening
• Polyp removal
• Investigation of lower gastrointestinal symptoms

Approved in Japan as Colonoscopy for:

• Colorectal cancer screening
• Polyp removal
• Investigation of lower gastrointestinal symptoms

Approved in China as Colonoscopy for:

• Colorectal cancer screening
• Polyp removal
• Investigation of lower gastrointestinal symptoms

Approved in Switzerland as Colonoscopy for:

• Colorectal cancer screening
• Polyp removal
• Investigation of lower gastrointestinal symptoms

Who Is Running the Clinical Trial?

Midwest Biomedical Research Foundation

Lead Sponsor

Trials

26

Recruited

9,300+