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AI eye on polyps: could a computer match the microscope?

NCT ID NCT07738484

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 840 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

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

45 to 80 years

Sex

Anyone

Healthy volunteers

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

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

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  1. The official record

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