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

NCT03952611 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1203

Last updated 2023-03-16

No results posted yet for this study

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.

Conditions

  • Colorectal Adenoma

Interventions

PROCEDURE

Colonoscopy

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

DEVICE

distal Cap

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

DEVICE

Endocuff

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

Sponsors & Collaborators

  • Midwest Biomedical Research Foundation

    lead OTHER

Principal Investigators

  • Prateek Sharma, MD · Kansas City VA Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-16
Primary Completion
2021-12-20
Completion
2022-06-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03952611 on ClinicalTrials.gov