EndoCuff-assisted Versus Standard Colonoscopy for Adenoma Detection

Not Applicable

Completed

• Conditions: Polyp; Cancer; Adenoma
• Interventions: Device: Standard colonoscopy; Device: EndoCuff-assisted colonoscopy

• Registration Number: NCT02034929
• Lead Sponsor: Helios Albert-Schweitzer-Klinik Northeim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-06
• Study First Submitted QC: 2014-01-13
• Study First Posted: 2014-01-14
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-06
• Last Update Posted: 2018-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Standard colonoscopy	Standard colonoscopy	Standard Colonoscopy
Endocuff-assisted colonoscopy	EndoCuff-assisted colonoscopy	Endocuff-assisted colonoscopy

Primary Outcome Measures

Name	Time	Method
adenoma detection rate	25 minutes	completion of colonoscopy is defined as the time point at which the colonoscope has been pulled out of the body.

Secondary Outcome Measures

Name	Time	Method
total colonoscopy rate	25 minutes
procedure time	25 Minutes
polyp detection rate	1 Week
number of LGIN and HGIN adenomas detected	one week	LGIN= low grade intraepithelial neoplasia HGIN= high grade intraepithelial neoplasia
polyp distribution	25 minutes
withdrawal time	10 Minutes	without intervention time due to polypectomy
ileum intubation rate	10 minutes
adverse events	25 minutes	perforation, cuff loss, lacerations, major bleedings, drop of sO2 during colonoscopy

Trial Locations

Locations (4)

University Medical Center Göttingen; 🇩🇪 Göttingen, Germany

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

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

HELIOS Medical Center Siegburg, Department of Gastroenterology; 🇩🇪 Siegburg, Germany