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

March 15, 2023 updated by: Midwest Biomedical Research Foundation

Three Arm Prospective Randomized Controlled Trial of HD White-light Colonoscopy vs HD White-light Colonoscopy With Reveal® Distal Attachment Cap Versus HD White-light Colonoscopy With Endocuff Vision for the Detection of Colorectal Adenomas

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hypothesis and specific aims of the Study

We hypothesize that the detection rate of patients with colorectal adenomas will be higher with HDWL colonoscopy with Reveal® distal attachment cap and HDWL colonoscopy with Endocuff Vision compared to HDWL colonoscopy alone.

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:

  1. 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.
  2. 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.

Methodology:

This will be a prospective, randomized controlled study. Subjects referred for screening or surveillance colonoscopy will be prospectively enrolled. They will be randomized to one of 3 arms, i.e. HDWL colonoscopy HDWL colonoscopy with Reveal® cap or HDWL colonoscopy with Endocuff Vision.

Enrollment:

A member of the research team will approach a potential subject to discuss participation in the study, including background of the proposed study, inclusion and exclusion criteria, benefits and risks of the procedures and follow-up. If this is of interest to the subject, the informed consent form is discussed and presented. The subject must sign the consent form prior to enrollment. This form will have prior approval of the study site's Institutional Review Board (IRB). Failure to obtain informed consent renders the subject ineligible for the study.

Length of the study:

The duration of the study is expected to be approximately 12 months. Enrollment of study patients will cease when approximately 1227 patients have been enrolled.

Inclusion criteria

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

Exclusion criteria

  • 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

For three groups, moderate sedation will be administered in a standard fashion with intravenous midazolam, meperidine or fentanyl prior to undergoing colonoscopy.

The colonoscope (HDWL colonoscope or HDWL colonoscope with Reveal® cap or HDWL colonoscope with Endocuff Vision) will be inserted and cecum will be intubated. Photo documentation of the cecum will be performed. The colonic mucosa will be carefully visualized upon withdrawal of the colonoscope.

The time from the point of insertion of the colonoscope into the rectum to the intubation of cecum will be recorded with a stop watch by a research coordinator and will be documented as the "insertion time".

The time spent in inspecting the mucosa during withdrawal of the colonoscope will be documented as the "withdrawal time". During withdrawal of the colonoscope the stop watch will be stopped whenever mucosa is being cleaned, fluid/solid debris is suctioned or a polyp is being removed to ensure that the withdrawal time is the actual representation of the mucosal inspection time. Meticulous technique will be employed during the withdrawal phase with special efforts to visualize portions of colonic mucosa on the proximal aspects of haustral folds, flexures and valves.

All polyps detected will be documented: size, location, and morphology (using the Paris classification - Appendix A). Photo documentation of the polyps will be performed.

Polyps will then be removed with a biopsy forceps or snare and sent for histopathological evaluation, each in a separate jar and labeled accordingly.

The bowel preparation will be evaluated and graded according to previously reported criteria using the Boston Bowel Preparation Scale (Appendix B). Complications including any mucosal trauma from the high definition colonoscope alone or with high definition colonoscope with Reveal® cap or Endocuff Vision, perforation or gastrointestinal bleeding (requiring intervention) will be recorded for three groups.

Study Type

Interventional

Enrollment (Actual)

1203

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Kansas City VA Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High-Definition White-light Colonoscopy
Using an instrument called colonoscope which is used to detect colonic polyps
Procedure: Colonoscopy
Using an instrument called colonoscope which is used to detect colonic polyps
Active Comparator: High-Definition White-light Colonoscopy With Reveal®
Using an instrument called cap at end of colonoscope which is used to straighten colon folds
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
Active Comparator: High-Definition White-light Colonoscopy With Endocuff Vision
Using an instrument called Endocuff at end of colonoscope which is used to straighten colon folds
Procedure: Colonoscopy
Using an instrument called colonoscope which is used to detect colonic polyps
Device: Endocuff
Using an instrument called Endocuff at end of colonoscope which is used to straighten colon folds

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma detection rate
Time Frame: Through the study (1 year)
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.
Through the study (1 year)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Adenomas per person
Time Frame: Through the study (1 year)
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.
Through the study (1 year)
detection rates of advanced adenomas
Time Frame: Through the study (1 year)
To compare the detection rates for advanced adenomas of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
Through the study (1 year)
detect rates of serrated polyps
Time Frame: Through the study (1 year)
To compare the detection rates for serrated polyps of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
Through the study (1 year)
detect rates of right sided adenomas
Time Frame: Through the study (1 year)
To compare the detection rates of right sided adenomas of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
Through the study (1 year)
to determine cecal intubation time
Time Frame: Through the study (1 year)
To compare the cecal intubation time of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
Through the study (1 year)
to determine insertion and withdrawal time
Time Frame: Through the study (1 year)
To compare the insertion and withdrawal time of the procedure of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
Through the study (1 year)
to determine complications
Time Frame: Through the study(1 year)
To compare the complications of procedure of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
Through the study(1 year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Midwest Biomedical Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2018

Primary Completion (Actual)

December 20, 2021

Study Completion (Actual)

June 10, 2022

Study Registration Dates

First Submitted

October 23, 2017

First Submitted That Met QC Criteria

May 14, 2019

First Posted (Actual)

May 16, 2019

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 15, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RND#00978

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a multi- center study and we will receive de identified data from other centered via REDCAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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