EndoRings Colonoscopy for Adenoma Detection
- Conditions
- Adenoma
- Interventions
- Device: EndoRingsDevice: Standard colonoscopy
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 225
- indication for colonoscopy (screening, surveillance, diagnostic)
- age ≥ 45 years
- ability to give informed consent
- 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
- Arm && Interventions
Group Intervention Description EndoRings EndoRings Colonoscopy is performed with the EndoRings attached Standard Colonoscopy Standard colonoscopy Standard colonoscopy without any additional devices
- Primary Outcome Measures
Name Time Method Adenoma detection rate during colonoscopy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Department of Gastroenterology, University Medical Center
🇩🇪Göttingen, Lower Saxony, Germany
HELIOS Medical Center Siegburg
🇩🇪Siegburg, Germany
HELIOS HSK Kliniken
🇩🇪Wiesbaden, Hessen, Germany
HELIOS St. Marienberg Klinik Helmstedt
🇩🇪Helmstedt, Germany
Helios Albert-Schweitzer-Hospital, Academic University Teaching Hospital
🇩🇪Northeim, Germany