ColoVision: Using computers to instantly find and describe colorectal polyps
| ISRCTN | ISRCTN68236490 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68236490 |
| IRAS number | 313559 |
| Secondary identifying numbers | CPMS 54150, IRAS 313559 |
- Submission date
- 30/01/2023
- Registration date
- 31/08/2023
- Last edited
- 31/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English Summary
Background and study aims
Colorectal cancer is a major health problem. Most colorectal cancers develop from precursor lesions (polyps), and early detection and removal of these polyps can reduce rate and improve outcome of colorectal cancer.
Colonoscopy is the gold standard test to detect and remove polyps, however it has some limitations including a significant polyp miss rate.
Computer aided detection (CADe) and diagnosis (CADx) of polyps is rapidly progressing and recent studies have shown promising results. However, there is still lack of high-quality data from well-designed and implemented randomised trials and hence the need for this study.
This is an investigator-initiated multi-centre randomised controlled trial aiming to investigate how an approved and CE marked CADe device can support endoscopists on detection and diagnosis of colorectal polyps.
Who can participate?
Adults over 18 years who are undergoing a colonoscopy.
What does the study involve?
You will be allocated to have either a standard colonoscopy or a colonoscopy using the WISE VISION device.
Participants will not be able to choose which of these options they have. Instead, participants will be randomly assigned to one or the other. This is to make the trial fair and enable us to compare the two options accurately.
If participants are allocated to standard colonoscopy, participants will undergo the procedure in the usual way. If participants are allocated to colonoscopy with the use of the WISE VISION (CAD) device participants will still undergo a standard colonoscopy, as per usual, but there will also be an additional screen and computer programme used, during the procedure, to help us identify polyps. You do not have to undergo any additional or extra procedures to what would usually be needed. In both groups, the participant's endoscopist will examine possible polyps and use their clinical judgement to decide on the appropriate treat the ment and management. The WISE VISION (CAD) device will not replace human assessment or alter any decision making during the participant's procedure.
What are the possible benefits and risks of participating?
This study will have no direct benefit to participants.
There are no additional risks of taking part in this study.
Where is the study run from?
Portsmouth Hospitals NHS Trust (UK)
When is the study starting and how long is it expected to run for?
November 2022 to December 2024
Who is funding the study?
NEC Corporation (Japan)
Who is the main contact?
Katie.siggens@porthosp.nhs.uk
Contact information
Scientific
Portsmouth Hospital University NHS Trust
Gastroenterology Department
Queen Alexandra Hospital
Southwick Hill Road, Cosham
Portsmouth
PO6 3LY
United Kingdom
| Phone | +44 2392286000 |
|---|---|
| Katie.siggens@porthosp.nhs.uk |
Principal Investigator
Portsmouth Hospital University NHS Trust
Queen Alexandra Hospital
Cosham
Portsmouth
PO6 3LY
United Kingdom
| Phone | +44 2392 286000 ext.1207 |
|---|---|
| pradeep.bhandari@porthosp.nhs.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | 43135 COLOVISION PIS v1.1 01-11-22.pdf |
| Scientific title | Real time computer aided detection and characterisation of colorectal polyps; a prospective multi-centre randomised controlled superiority trial (ColoVision) |
| Study acronym | ColoVision |
| Study hypothesis | The CAD device used in this study (WISE VISION®) can significantly improve endoscopists’ adenoma detection rate (ADR) as well as their real time optical diagnosis to reach PIVI threshold of 90% NPV, compared to endoscopists not using the CAD device. |
| Ethics approval(s) |
Approved 29/11/2022, London - Bloomsbury Research Ethics Committee (HRA RES Centre Manchester, 3rd Floor, Barlow House, 4 Minshull Street, Manchester, M1 3DZ, United Kingdom; +44 2071048272; bloomsbury.rec@hra.nhs.uk), ref: 22/PR/1174 |
| Condition | Detection and diagnosis of colorectal polyps |
| Intervention | Participants will be randomised to either standard colonoscopy or standard colonoscopy with CAD support. The addition of the CAD system means an extra screen will be in the endoscopy suite. There is no additional procedure or follow up for participants. Participants will undergo their colonoscopy and the number of polyps detected in each group will be recorded. Additional information regarding diagnosis (assessment of size, shape and type of polyp by both the endoscopist and the CADx system) will also be assessed. Polyps which are identified will be assessed and managed according to standard care. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | CAD system |
| Primary outcome measure | Adenoma detection rate in both groups. PIVI-2: NPV of adenoma diagnosis in diminutive (<5mm) rectosigmoid polyps in both groups measured during procedure |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 29/11/2022 |
| Overall study end date | 08/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 654; UK Sample Size: 400 |
| Participant inclusion criteria | 1. Adults over 18 years who are undergoing a colonoscopy 2. Able to give informed consent |
| Participant exclusion criteria | 1. Pregnant patients 2. Poor bowel preparation 3. Polyposis syndrome 4. Inflammatory bowel conditions 5. Incomplete colonoscopy |
| Recruitment start date | 08/02/2023 |
| Recruitment end date | 08/06/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Worthing
BN11 2DH
United Kingdom
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
London
SE5 9RS
United Kingdom
Cosham
Portsmouth
PO6 3LY
United Kingdom
Sponsor information
Hospital/treatment centre
Queen Alexandra Hospital
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
England
United Kingdom
| Phone | +44 2392 286236 |
|---|---|
| Joe.Shoebridge@porthosp.nhs.uk | |
| Website | http://www.porthosp.nhs.uk/ |
"ROR" |
https://ror.org/009fk3b63 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Location
- Japan
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.1 | 01/11/2022 | 08/06/2023 | No | Yes |
| Protocol file | version 1.0 | 18/08/2022 | 08/06/2023 | No | No |
Additional files
Editorial Notes
30/01/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
