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

Completed · Not applicable

Conditions studied: Colorectal Adenoma

In brief

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.

Key facts

Study ID

NCT03952611

Run by

Midwest Biomedical Research

People needed

1203

Starts

2018-03-16

Expected to finish

2022-06-10

Last updated by the study team

2023-03-16

Who can join

Age: 18 and older, up to 110. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Referral for screening or surveillance colonoscopy
• Ability to provide informed consent

You may not qualify if…

• Prior history of colon cancer
• History of inflammatory bowel disease
• Prior surgical resection of any part of the colon
• Use of anti-platelet agents or anticoagulants that precludes the removal of polyps during the procedure
• History of polyposis syndrome or HNPCC
• Inability to give informed consent
• Family history of colon cancer in a first degree relative < 60 years or two first degree relatives with colorectal cancer

Where it is running

• Kansas City VA Hospital — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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