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AI eyes colon polyps: can it spot the dangerous ones?

NCT ID NCT05754229

Diagnosis Sponsor: Ismail Gögenur Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This trial tests how accurately an AI system, called GI Genius, can identify which polyps found during a colonoscopy are adenomas, the type that can become cancer. About 395 adults undergoing screening, diagnostic, or surveillance colonoscopy will receive the AI-assisted procedure. Researchers will compare the AI's real-time characterization with the lab analysis of each removed polyp to measure its accuracy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AI-assisted colonoscopy using the GI Genius system, which helps detect and characterize polyps in real time
What this could lead to
If the AI proves accurate, it could help doctors identify harmless polyps during colonoscopy and avoid removing them, reducing unnecessary procedures.
What could go wrong
The AI may misclassify polyps, leading to missed adenomas or unnecessary removals. This is a quality assurance study, not a treatment trial, so it won't change outcomes directly.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

395 people

The number who actually took part.

Started

Oct 2022

Finished

Apr 2026

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Referred for screening colonoscopy due to a positive faecal immunochemical test (FIT) or for * Diagnostic colonoscopy due to symptoms/signs or * Post-polypectomy surveillance colonoscopy (only patients who had all detected polyps removed in the previous colonoscopy) Exclusion Criteria: * Referral for removal of previous detected polyps * Emergency colonoscopy * Control colonoscopy due to inflammatory bowel disease (IBD)

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Conditions

The condition(s) this trial relates to.

colorectal adenoma colorectal cancer colorectal neoplasm polyp of large intestine

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal adenoma Colorectal cancer Colorectal neoplasms

Contacts and locations

Locations

  • Holbæk Hospital

    Holbæk, 4300, Denmark

  • Nykøbing Falster County Hospital

    Nykøbing Falster, 4800, Denmark

  • Næstved Hospital

    Næstved, 4700, Denmark

  • Zealand University Hospital

    Køge, 4600, Denmark

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