EndoRings Colonoscopy for Adenoma Detection (ER)

February 10, 2019 updated by: Helios Albert-Schweitzer-Klinik Northeim

EndoRings Versus Standard Colonoscopy for Adenoma Detection

Adenoma detection rate (ADR) in colon cancer screening is most important for avoiding colon cancer development. Recent studies suggest a benefit of endoscopic devices attached to the distal tip of the colonoscope for improving the ADR. This work is the first GERMAN randomized controlled trial comparing standard colonoscopy with EndoRIngs-assisted colonoscopy.

EndoRings is a new FDA approved device that is attached to the distal tip of the colonoscope. Better Polyp detection is suspected by flattening the mucosal folds during withdrawal

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

225

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
      • Helmstedt, Germany
        • Recruiting
        • Helios St. Marienberg Klinik Helmstedt
        • Contact:
        • Principal Investigator:
          • Detlev Ameis, Prof.Dr.med.
      • Northeim, Germany, 37154
        • Recruiting
        • Helios Albert-Schweitzer-Hospital, Academic University Teaching Hospital
        • Contact:
        • Principal Investigator:
          • Tobias Meister, M.D.
        • Sub-Investigator:
          • Martin Floer, M.D.
        • Sub-Investigator:
          • Döner Ufuk
      • Siegburg, Germany
        • Recruiting
        • HELIOS Medical Center Siegburg
        • Contact:
        • Principal Investigator:
          • Michael Schepke, Prof.Dr.med.
    • Hessen
    • Lower Saxony
      • Göttingen, Lower Saxony, Germany, 37075
        • Recruiting
        • Department of Gastroenterology, University Medical Center

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

41 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • indication for colonoscopy (screening, surveillance, diagnostic)
  • age ≥ 45 years
  • ability to give informed consent

Exclusion Criteria:

  • pregnancy
  • age <45 years
  • known colonic strictures
  • chronic inflammatory bowel disease
  • active inflammation
  • s/p colonic resection
  • bleeding disorder

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: EndoRings
Colonoscopy is performed with the EndoRings attached
Device: EndoRings
EndoRings-assisted colonoscopy
Active Comparator: Standard Colonoscopy
Standard colonoscopy without any additional devices
Device: Standard colonoscopy
Standard colonoscopy without any additional devices

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adenoma detection rate
Time Frame: during colonoscopy
during colonoscopy

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, Prof. Dr., HELIOS Albert-Schweitzer Klinik
  • Principal Investigator: Ralf Kiesslich, Prof. Dr., HELIOS HSK Kliniken Wiesbaden

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 (Actual)

March 27, 2018

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

March 6, 2018

First Submitted That Met QC Criteria

March 16, 2018

First Posted (Actual)

March 19, 2018

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRC 047721

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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