EndoRings Colonoscopy vs Standard Colonoscopy

September 18, 2019 updated by: Douglas K. Rex, Indiana University

A Randomized Trial Comparing the Adenoma Detection Rates Between EndoRings Colonoscopy (EC) and Standard Colonoscopy (SC).

The study aims to compare the results between a standard colonoscopy to a colonoscopy with an attachment on the distal end of the colonoscope.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This will be a prospective, randomized controlled study. Subjects referred for screening or surveillance colonoscopy will be prospectively enrolled. This study aims to compare the adenoma detection rates between EndoRings colonoscopy (EC) and Standard colonoscopy (SC). It is assumed that the proportion of patients with at least one adenoma would be 25% with SC and 35% with EC.

Study Type

Interventional

Enrollment (Actual)

592

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Screening or Surveillance Colonoscopy
  • Able to provide written informed consent

Exclusion Criteria:

  • Known narrow colon or colon stenosis
  • Personal history of Colorectal cancer
  • History of inflammatory bowel disease
  • Familial adenomatous polyposis syndrome (FAP)
  • Hyperplastic polyposis syndrome
  • Referral for incomplete colonoscopy or polyp clearance

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 Colonoscopy)
Standard colonoscopy with no device attachment.
Experimental: EndoRings Colonoscopy
Colonoscopy with EndoRings device attached to the distal end of the scope.
Device: EndoRings device
Subjects randomized to undergo a colonoscopy procedure with the EndoRings 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
Adenoma Detection Rates
Time Frame: During colonoscopy procedure
Number of participants with at least one adenoma detected, during Standard Colonoscopy compared with colonoscopy with EndoRings.
During colonoscopy procedure
Number of Adenomas Per Colonoscopy
Time Frame: During colonoscopy procedure
Comparison of the number of adenomas detected per colonoscopy between standard colonoscopy and EndoRings colonoscopy.
During colonoscopy procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Polyp Detection Rate
Time Frame: During colonoscopy procedure
Number of subjects with at least one polyp detected with Standard Colonoscopy compared to colonoscopy with EndoRings.
During colonoscopy procedure
Number of Detections Per Colonoscopy
Time Frame: During colonoscopy procedure
Comparison of the number of polyps detected per colonoscopy between EndoRings colonoscopy and Standard colonoscopy.
During colonoscopy procedure
Total Number of Detections
Time Frame: During colonoscopy procedure
Comparison of the total number of polyps detected and the total number of adenomas detected between EndoRings colonoscopy and Standard colonoscopy.
During colonoscopy procedure
Cecal Intubation Rate
Time Frame: During colonoscopy procedure
Comparison of cecal intubation rate (the number of procedures where the colonoscope was able to be inserted all the way to the cecum) between standard colonoscopy and EndoRings colonoscopy.
During colonoscopy procedure
Time Comparison for Each Method
Time Frame: During colonoscopy procedure

Comparison of the time required to reach the cecum, withdrawal time, and total procedure time.

Insertion time: time required to reach the cecum Withdrawal time: time calculated from when withdrawing is started in the cecum till the colonoscope is removed. This includes time spent washing, inspecting the colon and removing polyps.

Total procedure time: This is the sum of insertion and withdrawal times along with any time spent washing or removing polyps while in the cecum (before starting withdrawal).
During colonoscopy procedure
Patient Comfort Score
Time Frame: After colonoscopy was completed while patient was in recovery area of endoscopy unit
Comparison of patient comfort between Standard colonoscopy and EndoRings colonoscopy on a scale of 0 to 10 with 0 being no pain (best outcome) and 10 being worst imaginable pain (worst outcome).
After colonoscopy was completed while patient was in recovery area of endoscopy unit
Problems Encountered With Equipment
Time Frame: During colonoscopy procedure
Occurrences of slippage of EndoRings or of device being removed on insertion.
During colonoscopy procedure

Collaborators and Investigators

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

Sponsor

Indiana University

Collaborators

US Endoscopy

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)

January 19, 2018

Primary Completion (Actual)

September 13, 2018

Study Completion (Actual)

September 13, 2018

Study Registration Dates

First Submitted

January 2, 2018

First Submitted That Met QC Criteria

January 25, 2018

First Posted (Actual)

February 1, 2018

Study Record Updates

Last Update Posted (Actual)

September 20, 2019

Last Update Submitted That Met QC Criteria

September 18, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1711224972

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified data may be shared upon the discretion of the principal investigator.

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.

Yes

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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