Evaluation of Endorings-2-assisted Colonoscopy: a New Accessory for Improvement of Adenoma Detection Rate? (Endorings-2)

June 15, 2020 updated by: University Hospital Muenster

Screening colonoscopy for colorectal cancer is essential to diagnose and remove adenomas, precancerous stages of colorectal cancer. Unfortunately approximately 25 % of all adenomas are missed during the examination. Recently a new colonoscopy accessory, the Endorings-2 (EndoAid Ltd., Casearea, Israel), has been designed to improved the detection of adenomas during colonoscopy (adenoma detection rate).

Endorings-2 is a silicone-rubber device that is fitted on the colonoscope and is equipped with circular flexible silicon rings mechanically stretching the colonic folds during withdrawal.

This study aims to evaluate the efficacy of Endorings-2 to improve the adenoma detection rate in a prospective, blinded clinical trial. 292 patients with an indication for a screening colonoscopy shall be included (1:1 randomization in standard colonoscopy versus Endorings-2-assisted colonoscopy).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

292

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

  • Germany
    • NRW
      • Muenster, NRW, Germany, 48149

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 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with an indication for a screening colonoscopy.

Exclusion Criteria:

  • Patients under 18 years, pregnancy
  • Patients with prior colectomy or partial colectomy
  • Patients with a history of colorectal cancer
  • Patients with hereditary polyposis syndromes (FAP, HNPCC)
  • Patients with a stricture of the colon
  • Patients receiving anticoagulation prohibiting a colonoscopy
  • inability to have a patient education
  • bad conditions prohibiting a colonoscopy

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
Experimental: Endorings-assisted screening colonoscopy
146 patients with an indication for screening endoscopy will receive an Endorings-2-assisted colonoscopy.
Device: Endorings-2
292 patients with an indication for screening colonoscopy will be included. 146 patients will receive a standard colonoscopy and 146 patients will receive an Endorings-2 assisted colonoscopy (1:1 standard colonoscopy vs Endorings-2-assisted colonoscopy).
Other Names:
  • Endorings-2 (EndoAid Ltd, Caesarea, Israel)
No Intervention: Standard screening colonoscopy
146 patients with an indication for screening endoscopy will receive a standard colonoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the adenoma detection rate during screening colonoscopy
Time Frame: Intraoperative. Adenomas detected directly during the examination.
The primary outcome of this study is the adenoma detection rate of the standard colonoscopy in comparison to the Endorings-assisted colonoscopy.
Intraoperative. Adenomas detected directly during the examination.

Collaborators and Investigators

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

Sponsor

University Hospital Muenster

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, 2018

Primary Completion (Anticipated)

August 30, 2021

Study Completion (Anticipated)

February 1, 2022

Study Registration Dates

First Submitted

December 20, 2017

First Submitted That Met QC Criteria

December 27, 2017

First Posted (Actual)

December 28, 2017

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 15, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-635-f-S

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Colonic Polyp

Clinical Trials on Endorings-2

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe