COLO-DETECT: Can an artificial intelligence device increase detection of polyps during colonoscopy?
| ISRCTN | ISRCTN10451355 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10451355 |
| IRAS number | 286426 |
| ClinicalTrials.gov number | NCT04723758 |
| Secondary identifying numbers | CPMS 48022, IRAS 286426 |
- Submission date
- 27/01/2021
- Registration date
- 12/02/2021
- Last edited
- 04/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
Background and Study Aims
Bowel cancer (also called colorectal cancer) is common, affecting 1 in 15 men and 1 in 18 women in the UK in their lifetime. Many bowel cancers develop from polyps. These polyps are small abnormal growths from the lining of the bowel. It is possible to remove polyps and therefore prevent them from progressing to colorectal cancer. The best tool for doing this is a procedure called colonoscopy (a camera test of the large bowel). However, colonoscopy does not pick up all polyps.
Because missed polyps can develop into bowel cancer, it is important to detect and remove as many polyps as possible during a colonoscopy. Many different things have been introduced to try to improve the ability to detect polyps, the most recent of which is artificial intelligence devices. GI Genius is an artificial intelligence device in the form of a box that is connected to existing colonoscopy equipment; it analyses the video images from the camera in real time. Any areas that may represent an abnormality are then highlighted within a green box, alerting the colonoscopist (person performing the camera test) to its presence. The area in the box can then be assessed more closely by the colonoscopist to decide whether it needs to be removed or not.
The COLO-DETECT trial will assess whether colonoscopists using GI Genius to assist them are able to detect more polyps (especially a type of polyp called an adenoma) during colonoscopy than when they don't use GI Genius. It will also gather data on many other aspects of the colonoscopy (including participants' experience of the procedure) to ensure that they are not adversely affected by using the GI Genius device.
Who can participate?
Adults who have been referred for a colonoscopy because of bowel symptoms, because they have had a colonoscopy for bowel problems before and need a follow-up procedure, or as part of the National Bowel Cancer Screening Programme. There are certain reasons why it is not appropriate to take part, which will be checked with people prior to enrolling them in the study.
What does the study involve?
People who agree to participate will be randomly allocated to have either a standard colonoscopy or a colonoscopy with GI Genius turned on for the procedure. Besides the use of GI Genius, the procedure will be entirely normal for the hospital where they are having their colonoscopy. Nurses looking after patients during their colonoscopy will record some details of the procedure as it happens. After the colonoscopy, the recovery from the procedure and discharge from the hospital will be as normal.
Participants will be given 2 questionnaires and asked to complete them the following day and return them to the study research team in a pre-paid envelope. Approximately 14 days after the colonoscopy a member of the research team will call the participant to ask if they have remained well since the procedure and record any details of visits to the GP or hospital in that time that were related to the colonoscopy. The research team will also review the care records of participants to gather further information about the procedure and any polyps that were identified. There will be no further contact from the research team after this.
What are the potential benefits and risks of participating?
People participating will potentially have a greater number of pre-cancerous polyps identified and removed during their colonoscopy, which may in turn reduce the likelihood of that individual subsequently developing bowel cancer.
There are not thought to be any risks resulting directly from the use of GI Genius, but if it does detect more polyps that are then removed then there is a small increase in the risk of complications such as bleeding or perforation (a small hole in the bowel) from the larger number of polyp removals. Bleeding or perforation may or may not require additional tests or treatment.
Where is the study run from?
South Tyneside and Sunderland NHS Foundation Trust (UK) in partnership with Newcastle University (UK). 8 hospital trusts across England, who will be inviting people to participate.
When is the study starting and how long is it expected to run for?
From March 2020 to May 2023
Who is funding the study?
Medtronic (Ireland) and the National Institute for Health Research (UK)
Who is the main contact?
Alexander Seager
alexander.seager@nhs.net
Contact information
Public
Research and Innovation
South Tyneside and Sunderland NHS Foundation Trust
Old Child and Family Block
South Tyneside District Hospital
Harton Lane
South Shields
NE34 0PL
United Kingdom
 ORCID ID |
0000-0002-2229-1553 |
|---|---|
| Phone | +441914041000 |
| alexander.seager@nhs.net |
Scientific
Research and Innovation
South Tyneside and Sunderland NHS Foundation Trust
Old Child and Family Block
South Tyneside District Hospital
Harton Lane
South Shields
NE34 0PL
United Kingdom
| ORCID ID |
0000-0002-2229-1553 |
|---|---|
| Phone | +441914041000 |
| alexander.seager@nhs.net |
Study information
| Study design | Multicentre two-arm interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | ISRCTN10451355_PIS_V1.2_25Jan21.pdf |
| Scientific title | COLO-DETECT: A randomised controlled trial of lesion detection at colonoscopy using the GI Genius™ artificial intelligence platform |
| Study acronym | COLO-DETECT |
| Study hypothesis | There is no difference in the number of adenomas detected per colonoscopy when colonoscopy is assisted by the GI Genius Artificial Intelligence Device compared to standard colonoscopy. |
| Ethics approval(s) | Approved 25/01/2021, West of Scotland REC 4 (Research Ethics, Ward 11, Dykebar Hospital, Grahamston Road, Paisley, PA2 7DE, UK; +44 (0)141 314 0213; WoSREC4@ggc.scot.nhs.uk), ref: 21-WS-0003 |
| Condition | Adenoma of the colon, adenoma of the rectum, colorectal polyps, colorectal cancer |
| Intervention | Current intervention as of 26/07/2021: Immediately prior to colonoscopy, recruited participants will be randomised (1:1) to either GI Genius-Assisted Colonoscopy (GGC) or Standard Colonoscopy (SC) using a secure web-based randomisation platform. The colonoscopy will then completed as per standard practice for the unit where the colonoscopy is performed, and procedural data will be collected. 14-days post-procedure, participant health records (including case notes and histology records) and endoscopy reports will be reviewed, to gather post-procedural data including the nature of polyps identified and removed, and participants will be contacted by telephone to capture the occurrence of any post-procedural adverse events. Participants will also be asked to complete validated patient-reported experience measures and health-related quality of life questionnaires the following day and return these to the study team by post in a pre-paid envelope. _____ Previous intervention: Immediately prior to colonoscopy, recruited participants will be randomised (1:1) to either GI Genius-Assisted Colonoscopy (GGC) or Standard Colonoscopy (SC) using a secure web-based randomisation platform. The colonoscopy will then completed as per standard practice for the unit where the colonoscopy is performed, and procedural data will be collected. 14-days post-procedure, participant health records (including case notes and histology records) and endoscopy reports will be reviewed, and participants will be contacted by telephone to gather post-procedural data including the nature of polyps identified and removed, and occurrence of any post-procedural adverse events. Participants will also be asked to complete validated patient-reported experience measures and health-related quality of life questionnaires the following day and return these to the study team by post in a pre-paid envelope. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | - |
| Primary outcome measure | 1. Mean Adenomas per Procedure (MAP), the average number of adenomas detected per colonoscopy, measured from procedural data, participant health records, and endoscopy reports collected at 14 days post-procedure |
| Secondary outcome measures | 1. Adenoma Detection Rate (ADR), the proportion of colonoscopies in which one or more adenomas was detected, measured from procedural data, participant health records, and endoscopy reports collected at 14 days post-procedure 2. MAP in the 'screening' participant population, measured from procedural data, participant health records, and endoscopy reports collected at 14 days post-procedure 3. MAP in the 'symptomatic' participant population, measured from procedural data, participant health records, and endoscopy reports collected at 14 days post-procedure 4. ADR in the 'screening' participant population in whom at least one adenoma is detected at colonoscopy, measured from procedural data, participant health records, and endoscopy reports collected at 14 days post-procedure 5. ADR in the 'symptomatic' participant population in whom at least one adenoma is detected at colonoscopy, measured from procedural data, participant health records, and endoscopy reports collected at 14 days post-procedure 6. Mean number of Polyps per Procedure (MPP), number of polyps per procedure detected at colonoscopy, measured from procedural data, participant health records, and endoscopy reports collected at 14 days post-procedure 7. MPP in the 'screening' participant population, measured from procedural data, participant health records, and endoscopy reports collected at 14 days post-procedure 8. MPP in the 'symptomatic' participant population, measured from procedural data, participant health records, and endoscopy reports collected at 14 days post-procedure 9. Polyp Detection Rate (PDR), the proportion of participants in whom at least one polyp is detected at colonoscopy, measured from procedural data, participant health records, and endoscopy reports collected at 14 days post-procedure 10. PDR in the 'screening' participant population, measured from procedural data, participant health records, and endoscopy reports collected at 14 days post-procedure 11. PDR in the 'symptomatic' participant population, measured from procedural data, participant health records, and endoscopy reports collected at 14 days post-procedure 12. Polyp location, size, morphology, and histology (if retrieved), measured from procedural data, participant health records, and endoscopy reports collected at 14 days post-procedure 13. Sessile Serrated Polyp (SSP) detection rate, measured from procedural data, participant health records, and endoscopy reports collected at 14 days post-procedure 14. Colorectal Cancer (CRC) detection rate, measured from procedural data, participant health records, and endoscopy reports collected at 14 days post-procedure 15. Advanced Adenoma (AA) detection rate, measured from procedural data, participant health records, and endoscopy reports collected at 14 days post-procedure 16. Caecal Intubation Rate, the proportion of colonoscopies in which the colonoscope reaches the furthest extent of the colon, measured from procedural data, participant health records, and endoscopy reports collected at 14 days post-procedure 17. Insertion time to caecum, the time taken to reach the furthest point of the large bowel, measured from procedural data, participant health records, and endoscopy reports collected at 14 days post-procedure 18. Total Procedure Time, measured from procedural data, participant health records, and endoscopy reports collected at 14 days post-procedure 19. Total Withdrawal Time, the time taken to remove the colonoscope from the furthest point of the colon in the absence of any polyps, measured from procedural data, participant health records, and endoscopy reports collected at 14 days post-procedure 20. Colonoscopist-assessed patient comfort score, measured from procedural data, participant health records, and endoscopy reports collected at 14 days post-procedure 21. Nurse-assessed patient comfort score, measured from procedural data, participant health records, and endoscopy reports collected at 14 days post-procedure 22. Patient-reported experience measured using a validated Patient-Reported Experience Measure (Newcastle ENDOPREM) at 1 day post-procedure 23. Patient-reported health-related quality of life measured using the EuroQoL EQ-5D-5L quality of life questionnaire at 1 day post-procedure 24. Projected future endoscopy workload, the need for further colonoscopy for each participant, according to national guidelines on polyp surveillance from procedural data, determined by the findings at the index colonoscopy, participant health records, and endoscopy reports collected at 14 days post-procedure 25. MAP according to the National Bowel Cancer Screening Programme (BCSP) status of colonoscopist, measured from procedural data, participant health records, and endoscopy reports collected at 14 days post-procedure 26. ADR according to BCSP status of colonoscopist, measured from procedural data, participant health records, and endoscopy reports collected at 14 days post-procedure 27. Change in the number of adenomas detected per colonoscopy, for each colonoscopist, over the course of the study, calculated as the MAP for the first 20% and the last 20% of participants chronologically for each colonoscopist, measured from procedural data, participant health records, and endoscopy reports collected at 14 days post-procedure 28. Change in the proportion of participants in whom at least one adenoma is detected during colonoscopy, for each colonoscopist, over the course of the study, calculated as the ADR for the first 20% and the last 20% of participants chronologically for each colonoscopist, measured from procedural data, participant health records, and endoscopy reports collected at 14 days post-procedure 29. MAP for each participating colonoscopist, from pre-study to intra-study for the Standard Colonoscopy (SC) arm only, to assess for a contamination or learning effect, measured from procedural data, participant health records, and endoscopy reports collected at 14 days post-procedure 30. ADR for each participating colonoscopist, from pre-study to intra-study for the SC arm only, to assess for a contamination or learning effect, measured from procedural data, participant health records, and endoscopy reports collected at 14 days post-procedure 31. Cost-effectiveness of GI Genius-Assisted Colonoscopy (GGC) versus SC, the cost of equipment, staff, histology, unplanned admission, and other related costs will be calculated from procedural data, participant health records, and endoscopy reports collected at 14 days post-procedure 32. MAP amongst colonoscopists not participating in the study, over the duration of the study, measured from data reported by endoscopy units as part of the normal endoscopy quality assurance programme collected at 14 days post-procedure 33. ADR amongst colonoscopists not participating in the study, over the duration of the study, measured from data reported by endoscopy units as part of the normal endoscopy quality assurance programme collected at 14 days post-procedure |
| Overall study start date | 01/03/2020 |
| Overall study end date | 31/05/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 2032 |
| Total final enrolment | 2032 |
| Participant inclusion criteria | 1. Aged ≥18 years 2. Capacity to provide informed consent 3. Referred for a diagnostic colonoscopy which is due to be performed by a colonoscopist who is able to perform GI Genius-assisted colonoscopy as part of the trial |
| Participant exclusion criteria | 1. ≥1 absolute contraindications to colonoscopy 2. Lacking capacity to give informed consent 3. Confirmed or expected pregnancy 4. Established or suspected large bowel obstruction or pseudo-obstruction 5. Known presence of colorectal cancer or polyposis syndromes 6. Known colonic strictures (meaning that the colonoscopy may be incomplete) 7. Known active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis) 8. Inflammatory Bowel Disease (IBD) surveillance procedures 9. On antiplatelet agents or anticoagulants and have not stopped this for the procedure (as polyps cannot be removed and thus histology cannot be confirmed) 10. Attending for a planned therapeutic procedure or assessment of a known lesion 11. Referred with polyps identified on Bowel Scope procedure (Bowel Scope is a UK screening programme where all adults aged 55 are offered a one-off flexible sigmoidoscopy) |
| Recruitment start date | 29/03/2021 |
| Recruitment end date | 30/04/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Research and Innovation
Old Child and Family Block
Harton Lane
South Shields
NE34 0PL
United Kingdom
Hartlepool
TS24 9AH
United Kingdom
Kettering
NN16 8UZ
United Kingdom
Wolverhampton Road
Heath Town
Wolverhampton
WV10 0QP
United Kingdom
Burton Road
Kendal
LA9 7RG
United Kingdom
Marton Road
Middlesborough
TS4 3BW
United Kingdom
Rake Lane
North Shields
NE29 8NH
United Kingdom
Minerva Road
Farnworth
Bolton
BL4 0JR
United Kingdom
Freeman Road
High Heaton
Newcastle-upon-Tyne
NE7 7DN
United Kingdom
Worthing
BN11 2DH
United Kingdom
Sponsor information
Hospital/treatment centre
Research and Innovation
South Tyneside and Sunderland NHS Foundation Trust
Old Child and Family Block
South Tyneside District Hospital
Harton Lane
South Shields
NE34 0PL
England
United Kingdom
| Phone | +441914041000 |
|---|---|
| claire.livingstone@stft.nhs.uk | |
| Website | https://www.stft.nhs.uk/ |
"ROR" |
https://ror.org/044j2cm68 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Medtronic Inc.
- Location
- United States of America
Results and Publications
| Intention to publish date | 31/08/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Presentations will be made to regional, national, and international networks, symposia, and learned scientific societies. Results will be submitted for peer-reviewed publication in international journals. The Chief Investigator will take responsibility to present and publish the study outcomes. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V1.2 | 25/01/2021 | 12/02/2021 | No | Yes |
| Participant information sheet | version v2.0 | 27/04/2021 | 26/07/2021 | No | Yes |
| Protocol article | 09/06/2022 | 10/06/2022 | Yes | No | |
| Results article | 14/08/2024 | 04/03/2025 | Yes | No |
Additional files
- ISRCTN10451355_PIS_V1.2_25Jan21.pdf
- Uploaded 12/02/2021
- ISRCTN10451355_PIS_V2.0_27Apr2021.pdf
Editorial Notes
04/03/2025: Publication reference and total final enrolment added.
25/10/2022: The following changes have been made:
1. The recruitment start date has been changed from 29/03/2021 to 30/04/2023.
2. The recruitment end date has been changed from 14/09/2022 to 31/05/2023.
3. Worthing Hospital was added as a trial participating centre.
10/06/2022: Publication reference added.
26/07/2021: The following changes have been made:
1. The recruitment start date has been changed from 01/03/2021 to 29/03/2021.
2. The recruitment end date has been changed from 31/08/2022 to 14/09/2022.
3. Another version of the participant information sheet has been added.
4. Freeman Hospital has been added to the trial participating centres.
5. The intervention has been updated.
12/02/2021: The participant information sheet has been uploaded as an additional file.
11/02/2021: Trial’s existence confirmed by the National Institute for Health Research (NIHR).
