EndoRings Colonoscopy for Adenoma Detection (ER)

Helios Albert-Schweitzer-Klinik Northeim

Status: Unknown

Conditions: Adenoma

Treatments: Device: Standard colonoscopy; Device: EndoRings

Study type: Interventional

Funder types: Other

Identifiers

NCT03469622

HRC 047721

Details and patient eligibility

About

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

Enrollment: 225 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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225 participants in 2 patient groups

EndoRings

Active Comparator group

Description:

Colonoscopy is performed with the EndoRings attached

Treatment:

Device: EndoRings

Standard Colonoscopy

Active Comparator group

Description:

Standard colonoscopy without any additional devices

Treatment:

Device: Standard colonoscopy