AzTrials
AzTrials

Colorectal NeoplasmsB-ADENOMANCT03072472

BowelScope: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities

A study testing Endocuff Vision in people with Colorectal Neoplasms and Colonic Polyp, run by South Tyneside and Sunderland NHS Foundation Trust at 16 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study aims to assess the effect, if any, on the adenoma detection rate of BowelScope bowel cancer screening flexible sigmoidoscopies by using the Endocuff Vision device. Read more about this study

Who is it for?
Ages 55 to 61 yearsHealthy volunteers can take part
Conditions the study is for
Colorectal Neoplasms, Colonic Polyp, 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
3,221 participants
Where
16 sitesUnited Kingdom
Study dates
14 Feb 2017to 13 Feb 2018
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 55 to 61 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age 18 years and over
  • Referral for screening flexible sigmoidoscopy
  • Ability to give informed consent

Who cannot join

  • Absolute contraindications to flexible sigmoidoscopy
  • Established or suspicion of large bowel obstruction or pseudo-obstruction
  • Known colon cancer or polyposis syndromes
  • Known colonic strictures
  • Known severe diverticular segment (that is likely to impede sigmoidoscope passage)
  • Patients with known active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis)
Show all 9Show fewer
  • Patients lacking capacity to give informed consent
  • Patients who are on clopidogrel, warfarin, or other new generation anticoagulants which have not been stopped for the procedure as these will preclude polyp removal
  • Pregnancy

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United Kingdom16 sites

  • Bolton NHS Foundation Trust

    Bolton

  • Gloucestershire Hospitals NHS Foundation Trust

    Cheltenham, GL53 7AN

  • Dorset Healthcare University NHS Trust

    Dorchester

  • County Durham and Darlington NHS Foundation Trust

    Durham, DH1 5TW

  • University Hospitals of Morecambe Bay NHS Foundation Trust

    Kendal, LA9 7RG

  • Kettering General Hospital NHS Trust

    Kettering, NN16 8UZ

  • North West London Hospitals NHS Trust

    London, HA1 3UJ

  • Northumbria Healthcare NHS Foundation Trust

    North Shields, NE29 8NH

  • Oxford Health NHS Trust

    Oxford, OX3 9DU

  • Portsmouth Hospitals NHS Trust

    Portsmouth, PO6 3LY

  • Pennine Acute Hospitals NHS Trust

    Rochdale, OL12 0NB

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, S5 7AU

  • South Tyneside NHS Foundation Trust

    South Shields, Tyne and Wear, NE34 0PL

  • North Tees and Hartlepool NHS Trust

    Stockton-on-Tees, TS19 8PE

  • West Hertfordshire Hospitals NHS Trust

    Watford

  • The Royal Wolverhamptom NHS Trust

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

About this study

This study aims to assess the effect, if any, on the adenoma detection rate of BowelScope bowel cancer screening flexible sigmoidoscopies by using the Endocuff Vision device.

Read the detailed description

Colorectal cancer (CRC) is the fourth most common cancer in the UK with 40,000 new cases diagnosed annually. Most CRCs arise from the adenoma-carcinoma sequence which is a process that can take up to 10 years. Population screening programmes allow for earlier detection and removal of adenomas that may become malignant over time thus reducing CRC mortality. The English Bowel Scope Screening (BSS) programme began in 2013 and invites adults aged 55 and above for a one-off flexible sigmoidoscopy. The aim of the BSS programme is to reduce CRC development via the adenoma-carcinoma sequence through the detection and removal of adenomas from the left side of the colon. A large UK study has shown that offering one-off flexible sigmoidoscopy screening with adenoma clearance to adults aged 55-64 years reduced CRC incidence by 23% and mortality by 31%. Adenoma detection rate (ADR) is the most important marker of mucosal visualisation and is a surrogate marker of high quality colonoscopy. Data from colonoscopy studies have illustrated that a 1% increase in ADR is associated with a 3% decrease in interval colorectal cancer. In the BSS programme, ADR is comparatively lower the that shown in the initial sigmoidoscopy screening trials with a wide variation between endoscopists. Another marker that is often used is adenoma miss rates which also demonstrate a wide variation in clinical practice. Reasons for lesions not being detected at flexible sigmoidoscopy can be extrapolated from colonoscopy data and include; suboptimal technique; shorter withdrawal time; inadequate bowel preparation; presence of flat, depressed or subtle lesions; and the inability to visualise the proximal side of haustral folds, flexures (blind spots) and rectal valves. With the aid of the colonoscopic cuff Endocuff Vision®, the investigators aim to improve visualisation of the colonic mucosa by flattening colonic folds and manipulating them away from the field of forward view the investigators hypothesise that the Endocuff Vision® will improve adenoma detection rates by providing better fold retraction, a wider field of view and better scope tip stabilisation. This clinical randomised study will be conducted in subjects referred and scheduled for screening flexible sigmoidoscopy via the NHS English Bowel Scope Screening (BSS) Programme and will compare Endocuff Vision®-Assisted Flexible Sigmoidoscopy (EAFS) with Standard Flexible Sigmoidoscopy (SFS).

Being tested
Endocuff Vision
Keywords
Colorectal Cancer, Endoscopy, Screening, Colonic Adenoma, Adenoma Detection Rate, Endocuff, Endocuff Vision
Medical subject headings
Colorectal Neoplasms, Colonic Polyps, Adenoma, Digestive System Neoplasms, Intestinal Neoplasms, Neoplasms, Glandular and Epithelial, Digestive System Diseases, Intestinal Diseases

What participants receive

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

  • Endocuff VisionDevice

    The EndocuffTM (ARC Medical Design Ltd and Diagmed, UK) is a device (CE marked in UK) made of a soft plastic material with a unique dynamic shape. Endocuff Vision™ is placed snugly around the colonoscope tip prior to insertion. It does not project beyond the tip of the scope, providing an unrestricted view. It helps anchor the scope tip against the bowel wall to provide a stable platform of access. The soft, elastic projections are pushed back (recoiled) towards the scope shaft during insertion but evert during withdrawal to hold colon folds away from the field of view.

Study groups in NCT03072472
Study groupRoleWhat they receive
Endocuff-assisted Flexible SigmoidoscopyExperimentalPatients in this arm will receive their screening sigmoidoscopy with the Endocuff Vision in situ on the scope
Receives: Device: Endocuff Vision
Standard Flexible SigmoidoscopyNo interventionPatients in this arm will receive their screening sigmoidoscopy without the Endocuff on the scope

What is being measured

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

  1. Adenoma Detection Rate

    Proportion of examinations expressed as a percentage where at least one adenoma is found

    Measured: Day of procedure

Secondary outcomes (12)

  1. Mean adenomas detected per procedure

    Number of adenomas found in each procedure

    Measured: Day of procedure

  2. Rate of cuff exchange

    How often the cuff is removed

    Measured: Day of procedure

  3. Non-inferiority of complete withdrawal time in procedures where no polyps are detected

    Length of procedure in minutes and seconds

    Measured: Day of procedure

  4. Compare overall procedure time between groups

    Length of procedure in minutes and seconds

    Measured: Day of procedure

  5. Measure differences in ADR accounting for patient procedure based variables (e.g. accounting for extent of examination and bowel preparation).

    Proportion of examinations expressed as a percentage where at least one adenoma is found

    Measured: Day of procedure

  6. Compare the rate of discovered cancers between groups

    Number of cancers found

    Measured: On histology check 48-72 hours post procedure

  7. Examination extent between groups based on presumed anatomical location with a straight endoscope

    Anatomical location

    Measured: Day of procedure

  8. Examination extent between groups based on distance of insertion in centimetres with a straight endoscope

    Depth of insertion in centimetres

    Measured: Day of procedure

  9. Patient satisfaction between groups using the Gloucester scale of assessment of patient comfort

    Numerical 4 point patient comfort score

    Measured: Day of procedure

  10. Identify any difference in future colonoscopic workload produced by increased ADR in terms of number of patients referred for full colonoscopy between the EAFS and SFS groups.

    Number of additional colonoscopies required

    Measured: Day of procedure

  11. Compare the 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 to assess any learning curve effect.

    Proportion of examinations expressed as a percentage where at least one adenoma is found

    Measured: 18 months

  12. Compare the baseline ADR of each colonoscopist prior to trial recruitment with their individual ADR in patients where EndocuffTM Vision was not used.

    Proportion of examinations expressed as a percentage where at least one adenoma is found

    Measured: 18 months

Timeline

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

  1. First posted7 Mar 2017
  2. Study start14 Feb 2017
  3. Primary completion13 Feb 2018
  4. Study completion13 Feb 2018

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
3,221 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03072472
Sponsor's protocol ID
B-ADENOMA
Acronym
B-ADENOMA
Status last verified
Sep 2018
First submitted
16 Jan 2017
Last updated
6 Sep 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rees CJ, Brand A, Ngu WS, Stokes C, Hoare Z, Totton N, Bhandari P, Sharp L, Bastable A, Rutter MD, Verma AM, Lee TJ, Walls M; B-ADENOMA trial group comprises. BowelScope: Accuracy of Detection Using Endocuff Optimisation of Mucosal Abnormalities (the B-ADENOMA Study): a multicentre, randomised controlled flexible sigmoidoscopy trial. Gut. 2020 Nov;69(11):1959-1965. doi: 10.1136/gutjnl-2019-319621. Epub 2020 Apr 3.

    PubMed 32245908

Questions about this trial

What is this clinical trial studying?

A study testing Endocuff Vision in people with Colorectal Neoplasms and Colonic Polyp, run by South Tyneside and Sunderland NHS Foundation Trust at 16 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adenoma Detection Rate (time frame: Day of procedure). 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 NCT03072472, 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 6 Sep 2018.

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