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

Not Applicable

• Conditions: Colonic Adenoma; Colonic Neoplasms; Colonoscopy; Colonic Polyp
• Interventions: Device: Endorings-2

• Registration Number: NCT03385434
• Lead Sponsor: University Hospital Muenster

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2017-12-27
• Study First Posted: 2017-12-28
• Study Start: 2018-02-01
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-15
• Last Update Posted: 2020-06-16
• Primary Completion: 2021-08-30
• Study Completion: 2022-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 292

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endorings-assisted screening colonoscopy	Endorings-2	146 patients with an indication for screening endoscopy will receive an Endorings-2-assisted colonoscopy.

Primary Outcome Measures

Name	Time	Method
Evaluation of the adenoma detection rate during screening colonoscopy	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.

Trial Locations

Locations (1)

Unversity Clinic Muenster; 🇩🇪 Muenster, NRW, Germany