EndoCuff-assisted Versus Standard Colonoscopy for Adenoma Detection

Helios Albert-Schweitzer-Klinik Northeim

Status: Completed

Conditions: Cancer; Polyp; Adenoma

Treatments: Device: Standard colonoscopy; Device: EndoCuff-assisted colonoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02034929

HRS ID 003053

Details and patient eligibility

About

The EndoCuff is novel flexible cuff that can be attached to the distal tip of the colonoscope and helps to flatten large mucosal folds during withdrawal.

The study hypothesis is that the use of the Endocuff (EC) increases the adenoma detection rate during colonoscopy.

The study purpose is to compare EC-assisted colonoscopy with standard colonoscopy for polyp detection.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

indication for colonoscopy (screening, surveillance, diagnostic) ager ≥ 18 years ability to give informed consent

Exclusion criteria

• pregnancy
• age<18 years
• known colonic strictures
• chronic inflammatory bowel disease
• active inflammation
• s/p colonic resection

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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500 participants in 2 patient groups

Endocuff-assisted colonoscopy

Active Comparator group

Description:

Endocuff-assisted colonoscopy

Treatment:

Device: EndoCuff-assisted colonoscopy

Standard colonoscopy

Active Comparator group

Description:

Standard Colonoscopy

Treatment:

Device: Standard colonoscopy