Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities (ADENOMA)

September 15, 2015 updated by: South Tyneside and Sunderland NHS Foundation Trust
The purpose of this study is to determine if a new device, called the Endocuff Vision (a small plastic device attached to the end of the colonoscope which helps by holding the folds of the bowel back to give a clear view of the inside of the bowel) will significantly improve the detection of adenomas when used in all patients referred for colonoscopy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Bowel cancer is common in the United Kingdom, with around 1 in 16 men and 1 in 20 women developing it at some point in their lives. Most bowel cancers happen when a type of polyp (a growth in the bowel) called an adenoma becomes cancerous. Doctors use a camera test, known as a colonoscopy, to look inside the bowel and find these polyps and remove them. Removing precancerous polyps is known to reduce the chances of a person developing bowel cancer in the future. How good colonoscopists are at finding these polyps varies, and there is a lot of research into how to improve "adenoma detection rates".

A new device, called the Endocuff Vision (a small plastic device attached to the end of the colonoscope which helps by holding the folds of the bowel back to give a clear view of the inside of the bowel) has been shown to improve the rate of polyp detection at colonoscopy, and to make polyp removal easier. Previous small studies have shown that there is a significant improvement in detection of adenomas when an Endocuff Vision is used (with the rate of detection of adenomas rising from 49% to 66%). Colonoscopists who have used the Endocuff Vision before also feel that polyp removal is easier when it is on the colonoscope. This study will randomise patients coming for colonoscopy to have their procedure performed as usual (i.e. without the Endocuff Vision attached) or as an Endocuff Vision-assisted colonoscopy. The investigators will record polyp and adenoma detection rates, duration of procedure, participant comfort levels, and complications. All patients referred for colonoscopy (via the symptomatic service, surveillance procedures, and the Bowel Cancer Screening Programme) will be invited in 7 centres (a mixture of specialist centres and district general hospitals), recruiting a total of 1772 participants.

Study Type

Interventional

Enrollment (Anticipated)

1772

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
    • County Durham
      • Durham, County Durham, United Kingdom, DL3 6HX
        • Recruiting
        • County Durham and Darlington NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • John Silcock, MBBS, FRCP
      • Stockton-on-Tees, County Durham, United Kingdom, TS19 8PE
        • Recruiting
        • North Tees and Hartlepool NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Matthew Rutter, MBBS, FRCP
    • Middlesex
      • Harrow, Middlesex, United Kingdom, HA1 3UJ
        • Recruiting
        • St Mark's Hospital and Academic Institute
        • Contact:
        • Principal Investigator:
          • Brian Saunders, MBBS, FRCP
    • North Yorkshire
      • Middlesbrough, North Yorkshire, United Kingdom, TS4 3BW
        • Recruiting
        • South Tees Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Arvind Ramadas, MBBS,FRCP
    • Tyne and Wear
      • North Shields, Tyne and Wear, United Kingdom, NE29 8NH
        • Recruiting
        • Northumbria Healthcare NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Thomas Lee, MBBS, FRCP
      • South Shields, Tyne and Wear, United Kingdom, NE34 0PL
        • Recruiting
        • South Tyneside NHS Foundation Trust
        • Contact:
          • Wee Sing Ngu, MBChB, MRCS
          • Phone Number: 2899 01914041000
          • Email: wngu@nhs.net
        • Contact:
        • Principal Investigator:
          • Colin Rees, MBBS, FRCP
      • Sunderland, Tyne and Wear, United Kingdom, SR4 7TP
        • Recruiting
        • City Hospitals Sunderland NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • John Painter, MBBS, FRCP

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:

  1. All patients referred for screening, surveillance, or diagnostic colonoscopy
  2. All patients must be able to give informed consent

Exclusion Criteria:

  1. Patients with any absolute contraindications to colonoscopy
  2. Patients with established or suspicion of large bowel obstruction or pseudo-obstruction
  3. Patients with known colon cancer or polyposis syndromes
  4. Patients with known colonic strictures
  5. Patients with known severe diverticular segments (that is likely to impede colonoscope passage)
  6. Patients with active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis)
  7. Patients lacking capacity to give informed consent
  8. Pregnancy
  9. Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure.
  10. Patients who are attending for a therapeutic procedure or assessment of a known lesion

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Endocuff Vision-assisted Colonoscopy
Participants in this arm undergo Endocuff Vision-assisted colonoscopy
Device: Endocuff Vision
Endocuff Vision is a new device made of soft plastic material with a unique dynamic shape. It is manufactured by ARC Medical Design Limited and Diagmed in the United Kingdom. It has European Conformity in United Kingdom. The core is made of polypropylene and the 'finger like' projections are made of a thermoplastic elastomer. It comes in four colour coded sizes (purple, blue, green and orange) to fit a range of paediatric and adult colonoscopes. Endocuff Vision is the more updated version of device that has only one proximal row of more rounded finger-like projections. It is mounted at the tip of the colonoscope and held on by friction (pull-off force is a minimum of 10 Newtons).
No Intervention: Standard Colonoscopy
Participants in this arm undergo standard colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma detection rate
Time Frame: 10 months
A difference in adenoma detection rate between Endocuff Vision-assisted colonoscopy and standard colonoscopy.
10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean adenomas detected per procedure
Time Frame: 10 months
A difference in mean adenomas detected per procedure between both groups
10 months
Rate of cuff exchange
Time Frame: 10 months
The rate of cuff exchange (that is, how often the cuff has to be removed) between both groups
10 months
Effect on duration of caecal intubation rates
Time Frame: 10 months
Duration of complete withdrawal time in procedures where no polyps are detected between both groups
10 months
Patient satisfaction using validated patient comfort Bowel Cancer Screening Programme (BCSP) questionnaires
Time Frame: 10 months
Patient satisfaction measured from no pain (0) to severe pain (3), episodes of discomfort from no discomfort (0) to frequent (more than 4 times)(3), length of discomfort from no discomfort (0) to more than 1 minute(3).
10 months
Increase in surveillance colonoscopies caused by increased adenoma detection rate
Time Frame: 10 months
Increase in surveillance colonoscopies due to increased adenoma detection rate in terms of number of potential follow up procedures based on British Society of Gastroenterology adenoma surveillance guidelines in both groups
10 months
Number of proximal sessile serrated polyps by histology
Time Frame: 10 months
Number of of proximal sessile serrated polyps in both groups
10 months
Polyp location
Time Frame: 10 months
Distribution of polyps in the colon in both groups by location
10 months
Adenoma detection rate of BCSP and non-BCSP endoscopists
Time Frame: 10 months
Adenoma detection rate of BCSP and non-BCSP colonoscopists
10 months
Change in adenoma detection rate of each endoscopist during the course of the trial
Time Frame: 10 months
Adenoma detection rate (ADR) of the first 20% of patients scoped by each colonoscopist with the last 20% of patients in each arm to identify any changes in ADR.
10 months
Adenoma detection rate of individual endoscopist before and after trial commencement
Time Frame: 10 months
Baseline ADR of each colonoscopist prior to trial recruitment with their individual ADR in patients where Endocuff Vision was not used.
10 months

Collaborators and Investigators

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

Sponsor

South Tyneside and Sunderland NHS Foundation Trust

Investigators

  • Principal Investigator: Colin Rees, MBBS, FRCP, South Tyneside and Sunderland NHS Foundation Trust

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

November 1, 2014

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

September 10, 2015

First Submitted That Met QC Criteria

September 15, 2015

First Posted (Estimate)

September 16, 2015

Study Record Updates

Last Update Posted (Estimate)

September 16, 2015

Last Update Submitted That Met QC Criteria

September 15, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 039/2014
  • 17718 (UK Clinical Research Network)
  • 1182104 (Registry Identifier: International Standard Randomised Controlled Trial Number)

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.

Clinical Trials on Colorectal Neoplasms

Clinical Trials on Endocuff Vision

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe