search
Back to results

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

Primary Purpose

Colorectal Polyps, Colorectal Adenomas

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Arc Endocuff (AEC 110, 120, 130, 140)
Cap
Standard colonoscope
Sponsored by
Helios Albert-Schweitzer-Klinik Northeim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Polyps focused on measuring adenoma detection rate, polyp detection rate, withdrawal time, coecal and ileum intubation rate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • University of Muenster
  • University Medical Center Göttingen
  • HELIOS St. Marienberg Klinik Helmstedt
  • HELIOS Albert-Schweitzer-Klinik
  • HELIOS Medical Center Siegburg
  • Wroclaw Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

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

Cap

Standard Colonoscope

Arm Description

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

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

Standard colonoscopy without any additional device

Outcomes

Primary Outcome Measures

Adenoma detection rate
Proportion of patients having at least one adenoma
Polyp detection rate
Proportion of patients having at least one adenoma

Secondary Outcome Measures

Bowel preparation result
Coecum intubation rate
Ileum intubation rate
Coecum intubation time
withdrawal time
mucosal laceration
severe bleeding
perforation

Full Information

First Posted
January 2, 2015
Last Updated
February 10, 2019
Sponsor
Helios Albert-Schweitzer-Klinik Northeim
search

1. Study Identification

Unique Protocol Identification Number
NCT02331836
Brief Title
Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy
Acronym
EC-Cap-SC
Official Title
Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy for Adenoma Detection: A Randomized Controlled European Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
February 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helios Albert-Schweitzer-Klinik Northeim

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Polyps, Colorectal Adenomas
Keywords
adenoma detection rate, polyp detection rate, withdrawal time, coecal and ileum intubation rate

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
561 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arc Endocuff (AEC 110, 120, 130, 140)
Arm Type
Active Comparator
Arm Description
Endocuff-assisted colonoscopy Colonoscopy with the Endocuff attached at the distal tip of the scope
Arm Title
Cap
Arm Type
Active Comparator
Arm Description
Cap-assisted colonoscopy Colonoscopy with the transparent Cap attached at the distal tip of the scope
Arm Title
Standard Colonoscope
Arm Type
Active Comparator
Arm Description
Standard colonoscopy without any additional device
Intervention Type
Device
Intervention Name(s)
Arc Endocuff (AEC 110, 120, 130, 140)
Intervention Type
Device
Intervention Name(s)
Cap
Intervention Description
Olympus Disposable distal attachment 15mm diameter, 4mm depth
Intervention Type
Device
Intervention Name(s)
Standard colonoscope
Primary Outcome Measure Information:
Title
Adenoma detection rate
Description
Proportion of patients having at least one adenoma
Time Frame
1 year
Title
Polyp detection rate
Description
Proportion of patients having at least one adenoma
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Bowel preparation result
Time Frame
one day
Title
Coecum intubation rate
Time Frame
one year
Title
Ileum intubation rate
Time Frame
one year
Title
Coecum intubation time
Time Frame
one day
Title
withdrawal time
Time Frame
one day
Title
mucosal laceration
Time Frame
one day
Title
severe bleeding
Time Frame
one day
Title
perforation
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Meister, Prof. Dr.med.
Organizational Affiliation
Helios Albert-Schweitzer-Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Muenster
City
Muenster
State/Province
North-Rhine Westphalia
ZIP/Postal Code
48149
Country
Germany
Facility Name
University Medical Center Göttingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
HELIOS St. Marienberg Klinik Helmstedt
City
Helmstedt
Country
Germany
Facility Name
HELIOS Albert-Schweitzer-Klinik
City
Northeim
ZIP/Postal Code
37154
Country
Germany
Facility Name
HELIOS Medical Center Siegburg
City
Siegburg
Country
Germany
Facility Name
Wroclaw Medical University
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy

We'll reach out to this number within 24 hrs