COLO-DETECT: Can an Artificial Intelligence Device Increase Detection of Polyps During Colonoscopy? (NCT04723758) | Clinical Trial Compass
CompletedNot Applicable
COLO-DETECT: Can an Artificial Intelligence Device Increase Detection of Polyps During Colonoscopy?
United Kingdom2,032 participantsStarted 2021-03-29
Plain-language summary
COLO-DETECT is a clinical trial to evaluate whether an Artificial Intelligence device ("GI Genius", manufactured by Medtronic) can identify more polyps (pre-cancerous growths of the bowel lining) during colonoscopy (large bowel camera test) than during colonoscopy without it.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Able to give informed consent
* 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:
* Absolute contraindications to colonoscopy
* 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
What they're measuring
1
Number of adenomas per participant detected at colonoscopy as indicated by the Mean Number of Adenomas per Procedure (MAP)
Timeframe: The number of adenomas detected in each procedure will be counted at 14 days post-procedure
Trial details
NCT IDNCT04723758
SponsorSouth Tyneside and Sunderland NHS Foundation Trust