Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy (EC-Cap-SC)

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

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

Study Overview

• Status: Completed
• Conditions: Colorectal Polyps; Colorectal Adenomas
• Intervention / Treatment: Device: Arc Endocuff (AEC 110, 120, 130, 140); Device: Cap; Device: Standard colonoscope

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 Type: Interventional
• Enrollment (Actual): 561
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Göttingen, Germany, 37075
    • University Medical Center Göttingen
  • Helmstedt, Germany
    • Helios St. Marienberg Klinik Helmstedt
  • Northeim, Germany, 37154
    • HELIOS Albert-Schweitzer-Klinik
  • Siegburg, Germany
    • HELIOS Medical Center Siegburg
  • North-Rhine Westphalia
    • Muenster, North-Rhine Westphalia, Germany, 48149
      • University of Muenster
• Poland
  • Wroclaw, Poland, 50-556
    • Wroclaw Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma detection rate	Proportion of patients having at least one adenoma	1 year
Polyp detection rate	Proportion of patients having at least one adenoma	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Helios Albert-Schweitzer-Klinik Northeim
• Investigators: Principal Investigator: Tobias Meister, Prof. Dr.med., Helios Albert-Schweitzer-Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: January 2, 2015
• First Submitted That Met QC Criteria: January 5, 2015
• First Posted (Estimate): January 6, 2015

Study Record Updates

• Last Update Posted (Actual): February 12, 2019
• Last Update Submitted That Met QC Criteria: February 10, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: adenoma detection rate; withdrawal time; polyp detection rate; coecal and ileum intubation rate
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: EC-CUFF-2015