Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-01-07 @ 11:05 PM
Study NCT ID:
NCT03385434
Status:
UNKNOWN
Last Update Posted:
2020-06-16
First Post:
2017-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Endorings-2-assisted Colonoscopy: a New Accessory for Improvement of Adenoma Detection Rate?
Sponsor:
University Hospital Muenster
Organization:
Study Overview
Official Title:
Evaluation of Endorings-2-assisted Colonoscopy: a New Accessory for Improvement of Adenoma Detection Rate?
Status:
UNKNOWN
Status Verified Date:
2020-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Endorings-2
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).
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: