Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy

Colorectal Polyps Clinical Trial

— EC-Cap-SC  

Official title:

Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy for Adenoma Detection: A Randomized Controlled European Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02331836
• Other study ID #: EC-CUFF-2015
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: February 1, 2019

Study information

• Verified date: February 2019
• Source: Helios Albert-Schweitzer-Klinik Northeim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison of Endocuff-assisted, Cap-assisted and Standard colonoscopy for assessment of the adenoma detection rate (ADR)

Description:

The Endocuff is a medical device, approved in 2012 by the American Food and Drug Administration, which was also authorized by the European Agency for the Evaluation of Medicinal Products. The aim of the cuff is to optimize the view of the colonic mucosa. There is also a transparent cap on the market, which is used in colonoscopy for a better evaluation of the mucosa and polyp detection. The goal of this project is to conduct a prospective randomized trial for clarification of the hypotheses, whether the usage of the Endocuff increases the detection rate of adenomas compared to the transparent cap or compared to standard colonoscopy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 561
• Est. completion date: February 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Colonoscopy independent from indication

• Age = 18

• Patient is able to provide informed consent for the procedure

Exclusion Criteria:

• Inflammatory Bowel Disease stenosis

• Pregnant of nursing patient

• Acute diverticulitis

• Active Inflammatory Bowel Disease

• Age = 18

• Coagulation disorder (INR>1.4 , Thrombocytes < 50000/µl)

Related Conditions & MeSH terms

• Adenoma
• Colorectal Adenomas
• Colorectal Polyps

Intervention

Device:
• Arc Endocuff (AEC 110, 120, 130, 140)

• Cap
Olympus Disposable distal attachment 15mm diameter, 4mm depth
• Standard colonoscope

Locations

Country	Name	City	State
Germany	University Medical Center Göttingen	Göttingen
Germany	HELIOS St. Marienberg Klinik Helmstedt	Helmstedt
Germany	University of Muenster	Muenster	North-Rhine Westphalia
Germany	HELIOS Albert-Schweitzer-Klinik	Northeim
Germany	HELIOS Medical Center Siegburg	Siegburg
Poland	Wroclaw Medical University	Wroclaw

Sponsors (1)

Lead Sponsor	Collaborator
Helios Albert-Schweitzer-Klinik Northeim

Countries where clinical trial is conducted

Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma detection rate	Proportion of patients having at least one adenoma	1 year
Primary	Polyp detection rate	Proportion of patients having at least one adenoma	1 year
Secondary	Bowel preparation result		one day
Secondary	Coecum intubation rate		one year
Secondary	Ileum intubation rate		one year
Secondary	Coecum intubation time		one day
Secondary	withdrawal time		one day
Secondary	mucosal laceration		one day
Secondary	severe bleeding		one day
Secondary	perforation		one day