AzTrials
AzTrials

Colorectal NeoplasmsADENOMANCT02552017

Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities

A study testing Endocuff Vision in people with Colorectal Neoplasms and Colonic Polyps, run by South Tyneside and Sunderland NHS Foundation Trust at 7 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Colorectal Neoplasms, Colonic Polyps, Adenoma
What is being tested?
Endocuff Vision
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,772 participants
Where
7 sitesUnited Kingdom
Study dates
Nov 2014to Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

7 sites in 1 country.

Wee Sing Ngu, MBChB, MRCS contact

01914041000 ext. 2899

wngu@nhs.net

Gayle Clifford, BSc contact

01914041000 ext. 4756

gayle.clifford@stft.nhs.uk

7 sites in 1 country

United Kingdom7 sites, 7 recruiting

  • County Durham and Darlington NHS Foundation Trust

    Durham, County Durham, DL3 6HX

    John Silcock, MBBS, FRCP, 01325 380100, John.Silcock@cddft.nhs.uk

    John Silcock, MBBS, FRCP

    Recruiting

  • St Mark's Hospital and Academic Institute

    Harrow, Middlesex, HA1 3UJ

    Brian Saunders, MBBS, FRCP, 02082354000, b.saunders@imperial.ac.uk

    Brian Saunders, MBBS, FRCP

    Recruiting

  • South Tees Hospitals NHS Foundation Trust

    Middlesbrough, North Yorkshire, TS4 3BW

    Arvind Ramadas, MBBS, FRCP, 01642 854860, Arvind.Ramadas@stees.nhs.uk

    Arvind Ramadas, MBBS,FRCP

    Recruiting

  • Northumbria Healthcare NHS Foundation Trust

    North Shields, Tyne and Wear, NE29 8NH

    Thomas Lee, MBBS, FRCP, 0344 811 8111, Tom.Lee@northumbria-healthcare.nhs.uk

    Thomas Lee, MBBS, FRCP

    Recruiting

  • South Tyneside NHS Foundation Trust

    South Shields, Tyne and Wear, NE34 0PL

    Wee Sing Ngu, MBChB, MRCS, 01914041000 ext. 2899, wngu@nhs.net

    Gayle Clifford, BSc, 01914041000 ext. 4756, gayle.clifford@stft.nhs.uk

    Recruiting

  • North Tees and Hartlepool NHS Foundation Trust

    Stockton-on-Tees, County Durham, TS19 8PE

    Matthew Rutter, MBBS, FRCP, 01642 617617, Matt.rutter@nth.nhs.uk

    Matthew Rutter, MBBS, FRCP

    Recruiting

  • City Hospitals Sunderland NHS Foundation Trust

    Sunderland, Tyne and Wear, SR4 7TP

    John Painter, MBBS, FRCP, 0191 565 6256, John.Painter@chsft.nhs.uk

    John Painter, MBBS, FRCP

    Recruiting

Other trials in United Kingdom

About this study

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.

Read the 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.

Being tested
Endocuff Vision
Keywords
adenoma detection rate, Endocuff, Endocuff Vision, colonoscopy, bowel cancer screening, bowel cancer
Medical subject headings
Colorectal Neoplasms, Colonic Polyps, Adenoma, Intestinal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endocuff VisionDevice

    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).

Study groups in NCT02552017
Study groupRoleWhat they receive
Endocuff Vision-assisted ColonoscopyActive comparatorParticipants in this arm undergo Endocuff Vision-assisted colonoscopy
Receives: Device: Endocuff Vision
Standard ColonoscopyNo interventionParticipants in this arm undergo standard colonoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adenoma detection rate

    A difference in adenoma detection rate between Endocuff Vision-assisted colonoscopy and standard colonoscopy.

    Measured: 10 months

Secondary outcomes (10)

  1. Mean adenomas detected per procedure

    A difference in mean adenomas detected per procedure between both groups

    Measured: 10 months

  2. Rate of cuff exchange

    The rate of cuff exchange (that is, how often the cuff has to be removed) between both groups

    Measured: 10 months

  3. Effect on duration of caecal intubation rates

    Duration of complete withdrawal time in procedures where no polyps are detected between both groups

    Measured: 10 months

  4. Patient satisfaction using validated patient comfort Bowel Cancer Screening Programme (BCSP) questionnaires

    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).

    Measured: 10 months

  5. Increase in surveillance colonoscopies caused by increased adenoma detection rate

    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

    Measured: 10 months

  6. Number of proximal sessile serrated polyps by histology

    Number of of proximal sessile serrated polyps in both groups

    Measured: 10 months

  7. Polyp location

    Distribution of polyps in the colon in both groups by location

    Measured: 10 months

  8. Adenoma detection rate of BCSP and non-BCSP endoscopists

    Adenoma detection rate of BCSP and non-BCSP colonoscopists

    Measured: 10 months

  9. Change in adenoma detection rate of each endoscopist during the course of the trial

    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.

    Measured: 10 months

  10. Adenoma detection rate of individual endoscopist before and after trial commencement

    Baseline ADR of each colonoscopist prior to trial recruitment with their individual ADR in patients where Endocuff Vision was not used.

    Measured: 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2015 (estimated)
  2. Study startNov 2014
  3. Primary completionJun 2016 (estimated)
  4. Study completionJun 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,772 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02552017
Sponsor's protocol ID
039/2014
Other IDs
17718, 1182104
Acronym
ADENOMA
Status last verified
Sep 2015
First submitted
10 Sep 2015
Last updated
16 Sep 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Ngu WS, Bevan R, Tsiamoulos ZP, Bassett P, Hoare Z, Rutter MD, Clifford G, Totton N, Lee TJ, Ramadas A, Silcock JG, Painter J, Neilson LJ, Saunders BP, Rees CJ. Improved adenoma detection with Endocuff Vision: the ADENOMA randomised controlled trial. Gut. 2019 Feb;68(2):280-288. doi: 10.1136/gutjnl-2017-314889. Epub 2018 Jan 23.

    PubMed 29363535

Questions about this trial

What is this clinical trial studying?

A study testing Endocuff Vision in people with Colorectal Neoplasms and Colonic Polyps, run by South Tyneside and Sunderland NHS Foundation Trust at 7 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wee Sing Ngu, MBChB, MRCS (01914041000 ext. 2899, wngu@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adenoma detection rate (time frame: 10 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02552017, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in