EndoRings Colonoscopy for Adenoma Detection

Not Applicable

• Conditions: Adenoma

• Registration Number: NCT03469622
• Lead Sponsor: Helios Albert-Schweitzer-Klinik Northeim

Brief Summary

Adenoma detection rate (ADR) in colon cancer screening is most important for avoiding colon cancer development. Recent studies suggest a benefit of endoscopic devices attached to the distal tip of the colonoscope for improving the ADR. This work is the first GERMAN randomized controlled trial comparing standard colonoscopy with EndoRIngs-assisted colonoscopy.

EndoRings is a new FDA approved device that is attached to the distal tip of the colonoscope. Better Polyp detection is suspected by flattening the mucosal folds during withdrawal

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-06
• Study First Submitted QC: 2018-03-16
• Study First Posted: 2018-03-19
• Study Start: 2018-03-27
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-10
• Last Update Posted: 2019-02-12
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

• indication for colonoscopy (screening, surveillance, diagnostic)
• age ≥ 45 years
• ability to give informed consent

Exclusion Criteria

• pregnancy
• age <45 years
• known colonic strictures
• chronic inflammatory bowel disease
• active inflammation
• s/p colonic resection
• bleeding disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Adenoma detection rate	during colonoscopy

Trial Locations

Locations (5)

HELIOS HSK Kliniken; 🇩🇪 Wiesbaden, Hessen, Germany

Department of Gastroenterology, University Medical Center; 🇩🇪 Göttingen, Lower Saxony, Germany

HELIOS St. Marienberg Klinik Helmstedt; 🇩🇪 Helmstedt, Germany

Helios Albert-Schweitzer-Hospital, Academic University Teaching Hospital; 🇩🇪 Northeim, Germany

HELIOS Medical Center Siegburg; 🇩🇪 Siegburg, Germany