Standard Colonoscopy Versus Colonoscopy With Endocuff Vision

July 25, 2019 updated by: Douglas K. Rex, Indiana University

Prospective Randomized Controlled Trial of High-Definition White-light Colonoscopy Versus High-Definition White-light Colonoscopy With Endocuff Vision for Endpoints of Procedural Times

This study seeks to compare colonoscopy results between a standard method and one using a distal scope attachment (Endocuff Vision).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

For this study, subjects will be randomized into one of two groups (those who receive a standard colonoscopy and those who receive a colonoscopy with an Endocuff Vision attachment). Results will then be compared between the two; these include insertion time (time it takes to reach the cecum of the large intestine), inspection time (time spent examining the large intestine), the total time per each polypectomy (removal of polyps in the colon), and the total procedure time of the colonoscopy.

Study Type

Interventional

Enrollment (Actual)

200

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

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject referred for a screening or surveillance colonoscopy
  • Subject is aged 40 years or older
  • Subject has the 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 antiplatelet agents or anticoagulants that precludes the removal of polyps during the procedure
  • History of polyposis syndrome or HNPCC
  • Family history of colon cancer in a first-degree relative < 60 years or two first degree relatives with colorectal cancer
  • 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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Arm (Standard Colonscopy)
Standard colonoscopy with no device attachments
Experimental: Endocuff Vision
Colonoscopy with Endocuff Vision attached to distal end of scope
Device: Endocuff Vision
Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inspection Time Comparisons for Each Method (Standard vs. Endocuff Vision)
Time Frame: During the withdrawal portion of the colonoscopy procedure
Inspection time is time spent actually examining the colon. This was measured with a stopwatch and calculated by subtracting washing, suctioning, polypectomy and biopsy times from total withdrawal time. It was measured during colonoscopy by a study assistant using a stopwatch.
During the withdrawal portion of the colonoscopy procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insertion Time Comparisons for Each Method (Standard vs. Endocuff Vision)
Time Frame: During the insertion portion of the colonoscopy procedure
Insertion time is the time it takes from the colonoscope first being inserted to when the furthest section of the colon (which is called the cecum) is reached.
During the insertion portion of the colonoscopy procedure
Total Procedure Time Comparisons for Each Method (Standard vs. Endocuff Vision)
Time Frame: During the colonoscopy procedure
Total procedure time is the time from the initial insertion through the complete withdrawal of the scope
During the colonoscopy procedure
Detection Rates
Time Frame: During the colonoscopy procedure
The percentage of participants with at least one of the indicated polyp types found during standard colonoscopy compared to colonoscopy with Endocuff Vision.
During the colonoscopy procedure
Polyps Per Colonoscopy
Time Frame: During the colonoscopy procedure
Number of adenomas or sessile serrated polyps found per colonoscopy of Standard colonoscopy compared to Colonoscopy with Endocuff Vision.
During the colonoscopy procedure
Boston Bowel Preparation Score
Time Frame: During the withdrawal portion of the colonoscopy procedure after cleaning of the colon

Boston Bowel Preparation Score for patients receiving standard colonoscopy compared to colonoscopy with endocuff vision.

The total score for the Boston Bowel Preparation Scale ranges from 0 to 9, with higher score indicating a better bowel preparation quality.

The quality of the bowel preparation is assessed by the attending gastroenterologist.
During the withdrawal portion of the colonoscopy procedure after cleaning of the colon

Collaborators and Investigators

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

Sponsor

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)

December 11, 2017

Primary Completion (Actual)

April 18, 2018

Study Completion (Actual)

April 18, 2018

Study Registration Dates

First Submitted

November 29, 2017

First Submitted That Met QC Criteria

November 29, 2017

First Posted (Actual)

December 5, 2017

Study Record Updates

Last Update Posted (Actual)

August 6, 2019

Last Update Submitted That Met QC Criteria

July 25, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1709336500

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

De-identified data can be shared in the future upon request.

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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