Endorings™ Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection (Erings™)

January 31, 2019 updated by: Portsmouth Hospitals NHS Trust

Endorings™ Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection in Symptomatic and Asymptomatic Patients: A Randomised Controlled Trial

This study evaluates the impact of Endorings™ assisted colonoscopy on the number of polyps detected per patient compared to standard colonoscopy without use of EndoRings™. Half of the participants will receive EndoRings™ assisted colonoscopy, while the other half will receive standard colonoscopy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Colonoscopy is the gold standard for detection of colorectal neoplasia (polyps and cancers) but it is well known that colonoscopy is associated with a neoplasia miss rate of up to 25%.

One such method of reducing the neoplasia miss rate is cap assisted colonoscopy, where a cap is placed at the distal end of the colonoscope.The theory behind how the cap aids mucosal visualisation is that it depresses and flattens colonic folds, thereby improving visualisation on the proximal sides of folds.

Investigators aim to evaluate the impact of one such cap assisted device: EndoRings™ on polyp detection rates. EndoRings™ has been shown to improve polyp detection rate by 51% compared to 29% for standard colonoscopy in a recent tandem endoscopy study. EndoRings™ has received FDA approval.

Study Type

Interventional

Enrollment (Actual)

563

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

  • United Kingdom
    • Hampshire
      • Portsmouth, Hampshire, United Kingdom, PO63LY
        • Portsmouth University Hospital

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

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Symptomatic patients referred for colonoscopy age ≥ 55.
  • Asymptomatic patients age ≥55 undergoing screening or surveillance for polyps and cancers.

Exclusion Criteria:

  • History of Inflammatory bowel disease
  • History of Hereditary non polyposis colorectal cancer (HNPCC)
  • Familial adenomatous polyposis syndrome (FAP)
  • Hyperplastic polyposis syndrome
  • Known colonic stricture

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard colonoscopy
A standard colonoscope will be used to complete the procedure
Device: Standard colonoscopy
Other Names:
  • Current standard of care colonoscopy
Active Comparator: EndoRings™
An EndoRings™ device will be placed at the distal end of a standard colonoscope
Device: EndoRings™
Colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of polyps per patient
Time Frame: 14 months
To assess the impact of the Endorings™ cap on the number of polyps detected per patient as compared to standard colonoscopy.
14 months

Collaborators and Investigators

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

Sponsor

Portsmouth Hospitals NHS Trust

Collaborators

University of Portsmouth

Investigators

  • Principal Investigator: Pradeep Bhandari, MD, Portsmouth University 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 (Actual)

May 13, 2016

Primary Completion (Actual)

August 7, 2018

Study Completion (Actual)

August 7, 2018

Study Registration Dates

First Submitted

May 25, 2016

First Submitted That Met QC Criteria

May 27, 2016

First Posted (Estimate)

May 30, 2016

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHT/2015/101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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