Does using Endocuff Vision device increase the ability to find bowel polyps in bowel cancer screening endoscopy?

ISRCTN	ISRCTN30005319
DOI	https://doi.org/10.1186/ISRCTN30005319
Protocol serial number	33224
Sponsor	South Tyneside District Hospital
Funders	Arc Medical Design Limited, Norgine Limited

Submission date: 12/06/2017
Registration date: 16/06/2017
Last edited: 11/01/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-device-that-may-help-find-manage-polyps-bowel-during-cancer-screening-test-b-adenoma

Contact information

Mr Martin Walls
Public

South Tyneside District Hospital
Harton Lane
South Shields
Tyne and Wear
South Shields
NE34 0PL
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised; Interventional; Design type: Screening, Diagnosis, Prevention, Device
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The B-ADENOMA Study: Bowel Scope - Accuracy of Detection using ENdocuff Optimisation of Mucosal Abnormalities
Study acronym	B-ADENOMA
Study objectives	The aim of this study is to evaluate the effectiveness of using Endocuff Vision in detecting colonic adenomas (polyps in the bowel which may progress to bowel cancer), making sure the procedure is the same or better than the current procedure in all other aspects.
Ethics approval(s)	West Midlands Research Ethics Committee - Solihull, 20/01/2017, ref: 16/WM/0514
Health condition(s) or problem(s) studied	Specialty: Gastroenterology, Primary sub-specialty: Gastroenterology; UKCRC code/ Disease: Cancer/ Malignant neoplasms of digestive organs, Oral and Gastrointestinal/ Other diseases of the digestive system
Intervention	Participants undergo a endoscopy as per usual practice. Participants are randomly allocated to one of the groups using randomisation software, stratifying for age group and gender. Treatment arm: Participants in this arm have the Endocuff Vision mounted on the endoscope for the one-off flexible sigmoidoscopy. Control arm: The one-off flexible sigmoidoscopy is completed as normal, without the Endocuff Vision on the scope. Participants are followed up for 14 days after the test test to ensure there are no adverse events.
Intervention type	Other
Primary outcome measure(s)	Adenoma detection rate (ADR) is measured by histological examination of polyps, recorded 14 days after the procedure
Key secondary outcome measure(s)	1. Mean adenomas detected per procedure are measured by histological examination of polyps, at 14 days after the procedure 2. Rate of cuff exchange (that is, how often the cuff has to be removed) at the time of the procedure 3. Complete withdrawal time in procedures where no polyps are detected, measured using withdrawal times at the time of the procedure 4. Overall procedure time is measured at time of procedure 5. ADR accounting for patient procedure based variables (e.g. accounting for extent of examination and bowel preparation), recorded at the time of the procedure 6. Rate of discovered cancers is measured by histological examination of biopsies/polyps, recorded up to 14 days after the procedure 7. Examination extent is measured using anatomical assessment of and distance (in centimetres) of intubation at the time of the procedure 8. Patient satisfaction is measured using the modified Gloucester scale of assessment of patient comfort at day of procedure and 24 hours after 9. Differences in future colonoscopic workload produced by increased ADR is measured using the change in the number of patients referred for full colonoscopy at day of the procedure 10. Changes in ADR to assess any learning curve effect is measured using primary outcome data for the first and last 20% of cases per individual colonoscopist after recruitment has completed 11. ADR of each colonoscopist prior to trial recruitment compared with their individual ADR in patients where EndocuffTM Vision was not used is measured using data from the Bowel Cancer Screening programme collected pre-trial and after the trial has completed recruitment from primary outcome data
Completion date	30/08/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	3222
Total final enrolment	3222
Key inclusion criteria	1. Age 55 to 61 years (both male and female) 2. Referral for screening flexible sigmoidoscopy 3. Ability to give informed consent
Key exclusion criteria	1. Absolute contraindications to flexible sigmoidoscopy 2. Established or suspicion of large bowel obstruction or pseudo-obstruction 3. Known colon cancer or polyposis syndromes 4. Known colonic strictures 5. Known severe diverticular segment (that is likely to impede sigmoidoscope passage) 6. Patients with active colitis (ulcerative colitis, Crohn’s colitis, diverticulitis, infective colitis) 7. Patients lacking capacity to give informed consent 8. Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure 9. Pregnancy
Date of first enrolment	14/02/2017
Date of final enrolment	13/02/2018

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

South Tyneside District Hospital (Lead Centre)

Harton Lane
Tyne and Wear
South Shields
NE34 0PL
United Kingdom

St. Mark’s Hospital

Watford Road
Middlesex
HA1 3UJ
United Kingdom

Queen Alexandra Hospital

Southwick Hill Road
Cosham
PO6 3LY
United Kingdom

University Hospital North Tees

Hardwick Road
Hardwick
Stockton-on-Tees
TS19 8PE
United Kingdom

Bishop Auckland Hospital

Cockton Hill Road
Bishop Auckland
DL14 6AD
United Kingdom

North Tyneside General Hospital

Rake Lane
North Shields
NE29 8NH
United Kingdom

Queen Elizabeth Hospital

Queen Elizabeth Avenue
Gateshead
NE9 6SX
United Kingdom

Northern General Hospital

Herries Road
Sheffield
S5 7AU
United Kingdom

Fairfield General Hospital

Rochdale Old Road
Bury
BL9 7TD
United Kingdom

Gloucestershire Royal Hospital

Great Western Road
Gloucester
GL1 3NN
United Kingdom

New Cross Hospital

Wolverhampton Road
Heath Town
Wolverhampton
WV10 0QP
United Kingdom

Royal Bolton Hospital

Minerva Road
Farnworth
Bolton
BL4 0JR
United Kingdom

The Whittington Hospital

Magdala Avenue
London
N19 5NF
United Kingdom

Kettering General Hospital

Rothwell Road
Kettering
N19 5NF
United Kingdom

John Radcliffe Hospital

Headley Way
Headington
Oxford
OX3 9DU
United Kingdom

University College Hospital

235 Euston Road
Bloomsbury
London
NW1 2BU
United Kingdom

Charing Cross Hospital

Fulham Palace Road
London
W6 8RF
United Kingdom

Royal Lancaster Infirmary

Ashton Road
Lancaster
LA1 4RP
United Kingdom

Addenbrooke’s Hospital

Hills Road
Cambridge
CB2 0QQ
United Kingdom

Dorset County Hospital

Williams Avenue
Dorchester
DT1 2JY
United Kingdom

Watford General Hospital

Vicarage Road
Watford
WD18 0HB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	The datasets generated during and/or analysed during the current study is not expected to be made available due to no specific patient consent being given for this.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2020	26/11/2020	Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

11/01/2023: Updated Cancer Research UK lay summary link added to plain English summary field.
26/11/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
07/09/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/07/2018 to 13/02/2018.
2. The overall trial end date was changed from 01/10/2018 to 30/08/2018.
3. The intention to publish date was changed from 31/10/2019 to 31/12/2018.
13/06/2018: Cancer Research UK lay summary link added to plain English summary field.
14/05/2018: Internal review.
16/01/2018: Internal review.
06/11/2017: The ISRCTN prospective/retrospective flag compares the date of registration with the recruitment start date and does not include any grace period. The registration of this study was requested through the NIHR Portfolio and was finalised within 6 months of the recruitment starting.
11/08/2017: Internal review.