A 4-arm Clinical Trial of Fuse®, EndoCuff™, EndoRings™ and Standard Colonoscopy

February 15, 2019 updated by: Douglas K. Rex, Indiana University

A 4-arm Randomized Controlled Trial of Fuse®, EndoCuff™, EndoRings™ and Standard Colonoscopy

Adenoma detection rate (ADR) is a validated marker for reducing the risk of interval colorectal cancer after a screening colonoscopy. Recent studies suggest that novel devices attached to the colonoscope tip may improve the ADR of doctors performing a screening procedure

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Recent studies indicate that continuing medical education, time of colonoscopy during the day, forced longer withdrawal time, use of high definition colonoscopes all result in improving ADR although the gains have only been modest. To this end, adding novel devices to the tip of colonoscope may improve the ability of doctors to perform a better procedure. We therefore propose to identify the increase in ADR with 3 of these devices compared to standard colonoscopy. Fuse colonoscopy (2 cameras embedded at the side of the colonoscope tip providing an increased angle of view), EndoCuff (a plastic cap to fit the tip with flexible arms which hold the mucosa back aiding in inspection), EndoRings (similar to EndoCuff but the arms are wider) have been shown in tandem colonoscopy studies to improve the adenoma miss rates to 7-15% instead of the miss rates seen with standard colonoscopy which is usually about 40%. All these devices are FDA approved and are distributed in the United States.

Study Type

Interventional

Enrollment (Actual)

1262

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
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University 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

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Screening or Surveillance Colonoscopy

Exclusion Criteria:

  • Personal history of Colorectal cancer or Inflammatory bowel disease
  • Surgical resection of the colon or known colonic stricture
  • Personal or family history of Polyposis syndromes or Lynch syndrome
  • Referral for incomplete colonoscopy or known therapeutic polyp clearance
  • Severe diverticular disease
  • Referral for a positive hemoccult test in the past 6 months
  • Known coagulopathy
  • Inability to provide informed consent

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: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: FUSE® Colonoscopy
A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy
Device: FUSE® Colonoscopy
colonoscopy performed with the FUSE® (full spectrum endoscopy) system
ACTIVE_COMPARATOR: Colonoscopy with EndoCuff™
An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope
Device: Colonoscopy with EndoCuff™
colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope
ACTIVE_COMPARATOR: Colonoscopy with EndoRings™
An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope
Device: Colonoscopy with EndoRings™
colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope
ACTIVE_COMPARATOR: Standard Colonoscopy
A standard colonoscope will be used to complete the procedure
Device: Standard Colonoscopy
Current standard of care colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adenomas Per Colonoscopy
Time Frame: During Procedure
During Procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Detected Adenoma
Time Frame: During Procedure
During Procedure
Percentage of Participants With Detected Adenoma
Time Frame: During Procedure
During Procedure
Sessile Serrated Polyps Per Colonoscopy
Time Frame: During Procedure
During Procedure
Number of Participants With Detected Sessile Serrated Polyp
Time Frame: During Procedure
Number of patients with 1 or more sessile serrated polyps
During Procedure
Percentage of Participants With Detected Sessile Serrated Polyp
Time Frame: During Procedure
During Procedure
Number of Participants With a Detected Polyp
Time Frame: During Procedure
During Procedure
Percentage of Participants With a Detected Polyp
Time Frame: During Procedure
During Procedure
Cecal Insertion Time
Time Frame: During Procedure
During Procedure
Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion
Time Frame: During Procedure
During Procedure
Inspection Time
Time Frame: During Procedure
During Procedure
Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
Time Frame: During Procedure
During Procedure
Percent of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
Time Frame: During Procedure
During Procedure
Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
Time Frame: During Procedure
During Procedure
Percent of Sessile Serrated Polyps in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
Time Frame: During Procedure
During Procedure

Collaborators and Investigators

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

Sponsor

Indiana University

Investigators

  • Principal Investigator: Douglas Rex, MD, Indiana University

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)

February 1, 2015

Primary Completion (ACTUAL)

December 1, 2017

Study Completion (ACTUAL)

December 1, 2017

Study Registration Dates

First Submitted

January 13, 2015

First Submitted That Met QC Criteria

January 19, 2015

First Posted (ESTIMATE)

January 26, 2015

Study Record Updates

Last Update Posted (ACTUAL)

March 12, 2019

Last Update Submitted That Met QC Criteria

February 15, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1412036333

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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