EndoRings Colonoscopy for Adenoma Detection

Adenoma Clinical Trial

— ER  

Official title:

EndoRings Versus Standard Colonoscopy for Adenoma Detection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03469622
• Other study ID #: HRC 047721
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2019
• Source: Helios Albert-Schweitzer-Klinik Northeim
• Contact: Tobias Meister, Prof. Dr.
• Phone: +495551971244
• Email: tobias.meister[@]helios-gesundheit.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma

Intervention

Device:
• EndoRings
EndoRings-assisted colonoscopy
• Standard colonoscopy
Standard colonoscopy without any additional devices

Locations

Country	Name	City	State
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	HELIOS HSK Kliniken	Wiesbaden	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Helios Albert-Schweitzer-Klinik Northeim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma detection rate		during colonoscopy