COLO-DETECT: Can an Artificial Intelligence Device Increase Detection of Polyps During Colonoscopy?
NCT ID: NCT04723758
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
2032 participants
INTERVENTIONAL
2021-03-29
2023-04-20
Brief Summary
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Detailed Description
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Missed polyps can result in colorectal cancer, so it is imperative to detect and remove as many polyps as possible. Many different interventions have been introduced to improve polyp detection, the most recent of which is artificial intelligence devices. GI Genius is an artificial intelligence device which integrates with existing colonoscopy equipment and analyses the video feed from the colonoscope camera in real time. Any areas that may represent an abnormality are then highlighted (without any lag) within a green box, alerting the colonoscopist to its presence. The potential abnormality can then be assessed more closely by the colonoscopist to decide whether it needs to be removed or not.
COLO-DETECT is a 2-arm, prospective, randomised controlled trial to assess whether GI Genius is able to detect more polyps (specifically, adenomas) during colonoscopy than standard colonoscopy without GI Genius. The primary outcome will be the mean number of adenomas per procedure (MAP) and the key secondary outcome will be the proportion of colonoscopies in which one or more adenomas is detected (Adenoma Detection Rate - ADR). These are both important quality markers for colonoscopy; the study will be powered to detect a clinically meaningful difference in ADR, which will by default detect a meaningful difference in MAP as the sample size required for ADR is larger.
In addition to measuring the effect of GI Genius on polyp detection, COLO-DETECT will provide a health economics analysis concerning the use of GI Genius, perform long-term passive follow-up to examine for future outcomes related to colorectal polyps and colorectal cancer, and perform additional nested studies (subject to ethical approval) that examine the effect upon users (for example through a visual scanning study) and their experience of using the GI Genius.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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GI Genius-assisted colonoscopy (GGC)
In the GGC arm, participants will undergo colonoscopy as per standard care for the unit where they are having their procedure, except that at some point prior to commencing withdrawal of the colonoscope, a member of the endoscopy staff will turn on the GI Genius machine. This will remain operational from the time it is switched on until the end of the procedure.
GI Genius-assisted diagnostic colonoscopy
Participants will undergo diagnostic colonoscopy, which will be identical to the normal standard of care at the unit where they are undergoing their procedure, except that GI Genius will be turned on during the procedure.
Standard Colonoscopy (SC)
In the SC arm, participants will undergo colonoscopy as per standard care for the unit where they are having their procedure.
Diagnostic Colonoscopy
Diagnostic colonoscopy will be performed as per the standard of care for the unit where the patient is having their procedure.
Interventions
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GI Genius-assisted diagnostic colonoscopy
Participants will undergo diagnostic colonoscopy, which will be identical to the normal standard of care at the unit where they are undergoing their procedure, except that GI Genius will be turned on during the procedure.
Diagnostic Colonoscopy
Diagnostic colonoscopy will be performed as per the standard of care for the unit where the patient is having their procedure.
Eligibility Criteria
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Inclusion Criteria
* Patients attending for colonoscopy
* Through standard National Health Service (NHS) care (most commonly due to iron deficiency anaemia, altered bowel habit, weight loss, rectal bleeding, positive FIT (faecal immunohistochemical test) based on symptoms, those referred on basis of family history, abnormal cross- sectional imaging, polyp surveillance or post CRC surveillance)
* Through Bowel Cancer Screening Programme (FIT positive, surveillance)
* Colonoscopy to be performed by colonoscopist trained to perform GGC as part of the study
Exclusion Criteria
* Patients lacking capacity to give informed consent
* Confirmed or expected pregnancy
* Established or suspected large bowel obstruction or pseudo-obstruction
* Known presence of colorectal cancer or polyposis syndromes
* Known colonic strictures (meaning that the colonoscopy maybe incomplete)
* Known active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis)
* Inflammatory Bowel Disease (IBD) surveillance procedures
* Patients who are on clopidogrel, warfarin, or other antiplatelet agents or anticoagulants who have not stopped this for the procedure (as polyps cannot be removed and thus histology cannot be confirmed)
* Patients who are attending for a planned therapeutic procedure or assessment of a known lesion
* Patients referred with polyps identified on Bowel Scope procedure
18 Years
ALL
No
Sponsors
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North Wales Organisation for Randomised Trials in Health
OTHER
Newcastle University
OTHER
Medtronic
INDUSTRY
South Tyneside and Sunderland NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Colin J Rees, MBBS
Role: STUDY_DIRECTOR
Newcastle University, South Tyneside and Sunderland NHS Foundation Trust
Locations
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North Tees and Hartlepool NHS Foundation Trust
Hartlepool, County Durham, United Kingdom
University Hospitals of Morecambe Bay NHS Foundation Trust
Kendal, Cumbria, United Kingdom
Northumbria Healthcare NHS Foundation Trust
North Shields, North Tyneside, United Kingdom
Kettering General Hospital NHS Foundation Trust
Kettering, Northamptonshire, United Kingdom
University Hospitals Sussex NHS Foundation Trust
Worthing, Sussex, United Kingdom
South Tees Hospitals NHS Foundation Trust
Middlesbrough, Teesside, United Kingdom
The Newcastle-upon-Tyne Hospitals NHS Trust
Newcastle upon Tyne, Tyne & Wear, United Kingdom
South Tyneside and Sunderland NHS Foundation Trust
Sunderland, Tyne and Wear, United Kingdom
The Royal Wolverhampton NHS Trust
Wolverhampton, West Midlands, United Kingdom
Bolton NHS Foundation Trust
Bolton, , United Kingdom
Countries
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References
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Seager A, Sharp L, Neilson LJ, Brand A, Hampton JS, Lee TJW, Evans R, Vale L, Whelpton J, Bestwick N, Rees CJ; COLO-DETECT trial team. Polyp detection with colonoscopy assisted by the GI Genius artificial intelligence endoscopy module compared with standard colonoscopy in routine colonoscopy practice (COLO-DETECT): a multicentre, open-label, parallel-arm, pragmatic randomised controlled trial. Lancet Gastroenterol Hepatol. 2024 Oct;9(10):911-923. doi: 10.1016/S2468-1253(24)00161-4. Epub 2024 Aug 14.
Seager A, Sharp L, Hampton JS, Neilson LJ, Lee TJW, Brand A, Evans R, Vale L, Whelpton J, Rees CJ. Trial protocol for COLO-DETECT: A randomized controlled trial of lesion detection comparing colonoscopy assisted by the GI Genius artificial intelligence endoscopy module with standard colonoscopy. Colorectal Dis. 2022 Oct;24(10):1227-1237. doi: 10.1111/codi.16219. Epub 2022 Jun 28.
Other Identifiers
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286426
Identifier Type: OTHER
Identifier Source: secondary_id
21-WS-003
Identifier Type: OTHER
Identifier Source: secondary_id
10451355
Identifier Type: OTHER
Identifier Source: secondary_id
COLO-DETECT
Identifier Type: -
Identifier Source: org_study_id