Evaluation of Endorings-2-assisted Colonoscopy: a New Accessory for Improvement of Adenoma Detection Rate?
Endorings-2
1 other identifier
interventional
292
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2017
CompletedFirst Posted
Study publicly available on registry
December 28, 2017
CompletedStudy Start
First participant enrolled
February 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedJune 16, 2020
June 1, 2020
3.6 years
December 20, 2017
June 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (2)
Endorings-assisted screening colonoscopy
EXPERIMENTAL146 patients with an indication for screening endoscopy will receive an Endorings-2-assisted colonoscopy.
Standard screening colonoscopy
NO INTERVENTION146 patients with an indication for screening endoscopy will receive a standard colonoscopy.
Interventions
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).
Eligibility Criteria
You may qualify if:
- Patients with an indication for a screening colonoscopy.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unversity Clinic Muenster
Münster, North Rhine-Westphalia, 48149, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2017
First Posted
December 28, 2017
Study Start
February 1, 2018
Primary Completion
August 30, 2021
Study Completion
February 1, 2022
Last Updated
June 16, 2020
Record last verified: 2020-06