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High-Definition White-light Colonoscopy for Colorectal Adenomas (TRACE Trial)

N/A
Waitlist Available
Led By Prateek Sharma, MD
Research Sponsored by Midwest Biomedical Research Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through the study(1 year)
Awards & highlights

Summary

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.

Eligible Conditions
  • Colorectal Adenomas

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through the study(1 year)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through the study(1 year) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adenoma detection rate
Secondary outcome measures
Number of Adenomas per person
detect rates of right sided adenomas
detect rates of serrated polyps
+4 more

Trial Design

3Treatment groups
Active Control
Group I: High-Definition White-light ColonoscopyActive Control1 Intervention
Using an instrument called colonoscope which is used to detect colonic polyps
Group II: High-Definition White-light Colonoscopy With Reveal®Active Control2 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 VisionActive Control2 Interventions
Using an instrument called Endocuff at end of colonoscope which is used to straighten colon folds

Find a Location

Who is running the clinical trial?

Midwest Biomedical Research FoundationLead Sponsor
25 Previous Clinical Trials
8,115 Total Patients Enrolled
Prateek Sharma, MDPrincipal InvestigatorKansas City VA Hospital
18 Previous Clinical Trials
7,598 Total Patients Enrolled
~160 spots leftby Sep 2025
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