Status:
COMPLETED
COLO-DETECT: Can an Artificial Intelligence Device Increase Detection of Polyps During Colonoscopy?
Lead Sponsor:
South Tyneside and Sunderland NHS Foundation Trust
Collaborating Sponsors:
North Wales Organisation for Randomised Trials in Health
Newcastle University
Conditions:
Colonic Polyp
Colorectal Polyp
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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) duri...
Detailed Description
Colorectal cancer is common, affecting 1 in 15 men and 1 in 18 women in the UK in their lifetime. Many colorectal cancers develop from polyps via the adenoma-carcinoma sequence: there is a pre-cancero...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2023
Estimated Enrollment :
2032 Patients enrolled
Trial Details
Trial ID
NCT04723758
Start Date
March 29 2021
End Date
April 20 2023
Last Update
November 28 2023
Active Locations (10)
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1
North Tees and Hartlepool NHS Foundation Trust
Hartlepool, County Durham, United Kingdom, TS24 9AH
2
University Hospitals of Morecambe Bay NHS Foundation Trust
Kendal, Cumbria, United Kingdom, LA9 7RG
3
Northumbria Healthcare NHS Foundation Trust
North Shields, North Tyneside, United Kingdom, NE29 8NH
4
Kettering General Hospital NHS Foundation Trust
Kettering, Northamptonshire, United Kingdom, NN16 8UZ