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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03072472
Other study ID # B-ADENOMA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 14, 2017
Est. completion date February 13, 2018

Study information

Verified date September 2018
Source South Tyneside NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 3221
Est. completion date February 13, 2018
Est. primary completion date February 13, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years to 61 Years
Eligibility Inclusion Criteria:

1. Age 18 years and over

2. Referral for screening flexible sigmoidoscopy

3. Ability to give informed consent

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 known 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 which have not been stopped for the procedure as these will preclude polyp removal

9. Pregnancy

Study Design


Intervention

Device:
Endocuff Vision
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.

Locations

Country Name City State
United Kingdom Bolton NHS Foundation Trust Bolton
United Kingdom Gloucestershire Hospitals NHS Foundation Trust Cheltenham
United Kingdom Dorset Healthcare University NHS Trust Dorchester
United Kingdom County Durham and Darlington NHS Foundation Trust Durham
United Kingdom University Hospitals of Morecambe Bay NHS Foundation Trust Kendal
United Kingdom Kettering General Hospital NHS Trust Kettering
United Kingdom North West London Hospitals NHS Trust London
United Kingdom Northumbria Healthcare NHS Foundation Trust North Shields
United Kingdom Oxford Health NHS Trust Oxford
United Kingdom Portsmouth Hospitals NHS Trust Portsmouth
United Kingdom Pennine Acute Hospitals NHS Trust Rochdale
United Kingdom Sheffield Teaching Hospitals NHS Foundation Trust Sheffield
United Kingdom South Tyneside NHS Foundation Trust South Shields Tyne And Wear
United Kingdom North Tees and Hartlepool NHS Trust Stockton on Tees
United Kingdom West Hertfordshire Hospitals NHS Trust Watford
United Kingdom The Royal Wolverhamptom NHS Trust Wolverhampton

Sponsors (3)

Lead Sponsor Collaborator
South Tyneside NHS Foundation Trust ARC Medical Design Ltd, Norgine

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adenoma Detection Rate Proportion of examinations expressed as a percentage where at least one adenoma is found Day of procedure
Secondary Mean adenomas detected per procedure Number of adenomas found in each procedure Day of procedure
Secondary Rate of cuff exchange How often the cuff is removed Day of procedure
Secondary Non-inferiority of complete withdrawal time in procedures where no polyps are detected Length of procedure in minutes and seconds Day of procedure
Secondary Compare overall procedure time between groups Length of procedure in minutes and seconds Day of procedure
Secondary 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 Day of procedure
Secondary Compare the rate of discovered cancers between groups Number of cancers found On histology check 48-72 hours post procedure
Secondary Examination extent between groups based on presumed anatomical location with a straight endoscope Anatomical location Day of procedure
Secondary Examination extent between groups based on distance of insertion in centimetres with a straight endoscope Depth of insertion in centimetres Day of procedure
Secondary Patient satisfaction between groups using the Gloucester scale of assessment of patient comfort Numerical 4 point patient comfort score Day of procedure
Secondary 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 Day of procedure
Secondary 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 18 months
Secondary 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 18 months
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