EC-Cap-SC: Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy

Sponsor

Helios Albert-Schweitzer-Klinik Northeim (Other)

Overall Status

Completed

CT.gov ID

NCT02331836

Collaborator

(none)

561

Enrollment

Locations

Arms

Actual Duration (Months)

93.5

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Colorectal Polyps Colorectal Adenomas	Device: Arc Endocuff (AEC 110, 120, 130, 140) Device: Cap Device: Standard colonoscope	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

561 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Participant)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

Feb 1, 2019

Actual Study Completion Date :

Feb 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arc Endocuff (AEC 110, 120, 130, 140) Endocuff-assisted colonoscopy Colonoscopy with the Endocuff attached at the distal tip of the scope	Device: Arc Endocuff (AEC 110, 120, 130, 140)
Active Comparator: Cap Cap-assisted colonoscopy Colonoscopy with the transparent Cap attached at the distal tip of the scope	Device: Cap Olympus Disposable distal attachment 15mm diameter, 4mm depth
Active Comparator: Standard Colonoscope Standard colonoscopy without any additional device	Device: Standard colonoscope

Arm

Intervention/Treatment

Active Comparator: Arc Endocuff (AEC 110, 120, 130, 140)

Endocuff-assisted colonoscopy Colonoscopy with the Endocuff attached at the distal tip of the scope

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

Active Comparator: Cap

Cap-assisted colonoscopy Colonoscopy with the transparent Cap attached at the distal tip of the scope

Device: Cap

Olympus Disposable distal attachment 15mm diameter, 4mm depth

Active Comparator: Standard Colonoscope

Standard colonoscopy without any additional device

Device: Standard colonoscope

Outcome Measures

Primary Outcome Measures

Adenoma detection rate [1 year]
Proportion of patients having at least one adenoma
Polyp detection rate [1 year]
Proportion of patients having at least one adenoma

Secondary Outcome Measures

Bowel preparation result [one day]
Coecum intubation rate [one year]
Ileum intubation rate [one year]
Coecum intubation time [one day]
withdrawal time [one day]
mucosal laceration [one day]
severe bleeding [one day]
perforation [one day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Muenster	Muenster	North-Rhine Westphalia	Germany	48149
2	University Medical Center Göttingen	Göttingen		Germany	37075
3	HELIOS St. Marienberg Klinik Helmstedt	Helmstedt		Germany
4	HELIOS Albert-Schweitzer-Klinik	Northeim		Germany	37154
5	HELIOS Medical Center Siegburg	Siegburg		Germany
6	Wroclaw Medical University	Wroclaw		Poland	50-556