EndoCuff-assisted Versus Standard Colonoscopy for Adenoma Detection

Cancer Clinical Trial

Official title:

A Randomized Controlled Study to Compare EndoCuff-assisted With Standard Colonoscopy for the Detection of Adenomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02034929
• Other study ID #: HRS ID 003053
• Status: Completed
• Phase: N/A
• First received: January 6, 2014
• Last updated: March 6, 2018
• Start date: January 2014
• Est. completion date: July 2014

Study information

• Verified date: March 2018
• Source: Helios Albert-Schweitzer-Klinik Northeim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Cancer
• Polyp

Intervention

Device:
• EndoCuff-assisted colonoscopy
EC-assisted colonoscopy
• Standard colonoscopy
Standard colonoscopy

Locations

Country	Name	City	State
Germany	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

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	completion of colonoscopy is defined as the time point at which the colonoscope has been pulled out of the body.	25 minutes
Secondary	polyp detection rate		1 Week
Secondary	number of LGIN and HGIN adenomas detected	LGIN= low grade intraepithelial neoplasia HGIN= high grade intraepithelial neoplasia	one week
Secondary	polyp distribution		25 minutes
Secondary	procedure time		25 Minutes
Secondary	withdrawal time	without intervention time due to polypectomy	10 Minutes
Secondary	ileum intubation rate		10 minutes
Secondary	total colonoscopy rate		25 minutes
Secondary	adverse events	perforation, cuff loss, lacerations, major bleedings, drop of sO2 during colonoscopy	25 minutes