EndoCuff-assisted Versus Standard Colonoscopy for Adenoma Detection

March 6, 2018 updated by: Tobias Meister, Helios Albert-Schweitzer-Klinik Northeim

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Göttingen, Germany, 37575
        • University Medical Center Göttingen
      • Helmstedt, Germany, 38350
        • HELIOS St. Marienberg Hospital Helmstedt
      • Northeim, Germany, 37154
        • Helios Albert-Schweitzer-Hospital, Academic University Teaching Hospital
      • Siegburg, Germany, 53721
        • HELIOS Medical Center Siegburg, Department of Gastroenterology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Endocuff-assisted colonoscopy
Device: EndoCuff-assisted colonoscopy
EC-assisted colonoscopy
Active Comparator: Standard colonoscopy
Standard Colonoscopy
Device: Standard colonoscopy
Standard colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adenoma detection rate
Time Frame: 25 minutes
completion of colonoscopy is defined as the time point at which the colonoscope has been pulled out of the body.
25 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
polyp detection rate
Time Frame: 1 Week
1 Week
number of LGIN and HGIN adenomas detected
Time Frame: one week
LGIN= low grade intraepithelial neoplasia HGIN= high grade intraepithelial neoplasia
one week
polyp distribution
Time Frame: 25 minutes
25 minutes
procedure time
Time Frame: 25 Minutes
25 Minutes
withdrawal time
Time Frame: 10 Minutes
without intervention time due to polypectomy
10 Minutes
ileum intubation rate
Time Frame: 10 minutes
10 minutes
total colonoscopy rate
Time Frame: 25 minutes
25 minutes
adverse events
Time Frame: 25 minutes
perforation, cuff loss, lacerations, major bleedings, drop of sO2 during colonoscopy
25 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helios Albert-Schweitzer-Klinik Northeim

Investigators

  • Principal Investigator: Tobias Meister, M.D., Helios Albert-Schweitzer-Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

January 6, 2014

First Submitted That Met QC Criteria

January 13, 2014

First Posted (Estimate)

January 14, 2014

Study Record Updates

Last Update Posted (Actual)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 6, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRS ID 003053

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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