AI eye on polyps: could a computer match the microscope?
NCT ID NCT07738484
First seen Jul 31, 2026 · Last updated Jul 31, 2026
Summary
This trial tests whether an AI system called GI Genius can help doctors accurately tell apart small colorectal polyps (5 mm or less) during a colonoscopy—identifying which ones are harmless versus those that need monitoring. For each small polyp, doctors first record their own diagnosis, then activate the AI and record a second diagnosis after seeing its assessment. Both are compared to the final pathology report, the gold standard. The study involves about 840 adults undergoing routine colonoscopies at three Canadian centers, with no extra visits or procedures.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GI Genius CADx module (Medtronic), an AI-assisted computer-aided diagnosis device
- What this could lead to
- If successful, this AI tool could help doctors accurately identify harmless polyps during colonoscopy, potentially reducing unnecessary lab tests and lowering healthcare costs.
- What could go wrong
- The AI may not meet the accuracy thresholds needed for clinical use, and its performance could vary across different patient groups and settings. The study is observational, so it does not change patient care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 840 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Consecutive patients aged 45-80 years undergoing elective colonoscopy (screening, surveillance, or diagnostic) at three Canadian academic centres (CHUM, CUSM, St. Paul's Hospital), providing written informed consent before the procedure and before sedation. Patients become eligible for the analytic cohort if at least one diminutive polyp (≤5 mm) is detected during colonoscopy; those without an eligible polyp are recorded as screen failures. Key exclusions: inflammatory bowel disease, active colitis, coagulopathy/thrombocytopenia, familial polyposis syndrome, ASA \>III, emergency colonoscopy, or inadequate bowel preparation. Target: 840 patients (\~1,605 diminutive polyps) across the three centres over 24 months.
- Ages
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45 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Signed informed consent, obtained before the colonoscopy and before sedation * Age 45-80 years * Indication for elective colonoscopy (screening, surveillance, or diagnostic) * At least one diminutive polyp (≤5 mm) detected during the procedure (required for inclusion in the analytic cohort; consented patients without an eligible polyp are documented as screen failures) Exclusion Criteria: * Known inflammatory bowel disease * Active colitis * Coagulopathy or thrombocytopenia (INR ≥1.5 or platelets \<50×10⁹/L) * Familial polyposis syndrome * American Society of Anesthesiologists classification \>III * Emergency colonoscopy * Inadequate bowel preparation (Boston Bowel Preparation Scale \<6)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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