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NCT03385434 Clinical Trial

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

Colonoscopy Clinical Trial

— Endorings-2  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03385434
Other study ID # 2017-635-f-S
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2018
Est. completion date February 1, 2022

Study information
Verified date June 2020
Source University Hospital Muenster
Contact Frank Lenze, MD
Phone +492518357935
Email frank.lenze@uni-muenster.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Recruiting
Enrollment 292
Est. completion date February 1, 2022
Est. primary completion date August 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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).

Locations
Country Name City State
Germany Unversity Clinic Muenster Muenster NRW

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of the adenoma detection rate during screening colonoscopy 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.
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