Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03952611
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Midwest Biomedical Research Foundation

Brief 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.


Condition or disease Intervention/treatment Phase
Colorectal Adenoma Procedure: Colonoscopy Device: distal Cap Device: Endocuff Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1227 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Three Arm Randomized Control Trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Randomization will be done by computer allocation
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : March 16, 2018
Estimated Primary Completion Date : January 20, 2020
Estimated Study Completion Date : June 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952611


Contacts
Layout table for location contacts
Contact: Prateek Sharma, MD (816) 861-4700 ext 56735 prateek.sharma@va.gov

Locations
Layout table for location information
United States, Missouri
Kansas City VA Hospital Recruiting
Kansas City, Missouri, United States, 64128
Contact: April Higbee, RN, BSN    816-861-4700 ext 57456    april.higbee@va.gov   
Contact: Chandra Dasari, MD    816-861-4700 ext 55304      
Principal Investigator: Prateek Sharma, MD         
Sponsors and Collaborators
Midwest Biomedical Research Foundation
Investigators
Layout table for investigator information
Principal Investigator: Prateek Sharma, MD Kansas City VA Hospital

Publications:

Layout table for additonal information
Responsible Party: Midwest Biomedical Research Foundation
ClinicalTrials.gov Identifier: NCT03952611     History of Changes
Other Study ID Numbers: RND#00978
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is a multi- center study and we will receive de identified data from other centered via REDCAP

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms