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AI eye for colonoscopy: could software catch what doctors miss?

NCT ID NCT07744607

Diagnosis Sponsor: Ainex Corporation 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time

Summary

This trial evaluates an AI-based software tool designed to assist doctors in interpreting colonoscopy images. Using previously collected images and biopsy results from over a thousand patients, the study checks how accurately the AI classifies colorectal lesions as cancerous, precancerous, or benign. The goal is to see if this technology can reliably support doctors in detecting and assessing colorectal conditions during endoscopic exams.

What this could mean

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

Active substance
Artificial intelligence-based medical device software (ENAD-CADx-01) for endoscopic imaging assistance
What this could lead to
If proven accurate, this AI tool could help doctors better identify and classify colorectal lesions during colonoscopy, potentially improving early detection of cancer and reducing unnecessary biopsies.
What could go wrong
This is a retrospective study using stored images, not a real-time test. The AI's performance may differ in live procedures, and it may not generalize to other hospitals or patient groups.

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

1,114 people

The number who actually took part.

Started

Jan 2025

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population consisted of adults aged 18 years or older who underwent colonoscopy at Asan Medical Center and had previously collected colonoscopy images of colorectal lesions with corresponding histopathological results. Eligible images were retrospectively analyzed to evaluate the clinical performance of ENAD-CADx-01 in classifying lesions as neoplasm, hyperplastic polyp, or sessile serrated lesion.

Ages

18 years and older

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: * Participants aged 18 years or older at the time of colonoscopy. * Participants who underwent colonoscopy at Asan Medical Center and had colorectal lesion images available for retrospective analysis. * Participants with corresponding histopathological results available as the reference standard. * Colonoscopy images that met the predefined image quality requirements for analysis by ENAD-CADx-01. Exclusion Criteria: * Participants without corresponding histopathological results for the colorectal lesion. * Images with insufficient quality for analysis, including severe blur, obstruction, or inadequate visualization of the lesion. * Images or records with missing or insufficient data required for the clinical performance analysis. * Lesions that did not meet the predefined target lesion categories or other eligibility requirements specified in the clinical investigation plan.

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Conditions

The condition(s) this trial relates to.

colorectal neoplasm colorectal sessile serrated adenoma/polyp hyperplastic polyp polyp of colon

As listed by the trial registrant

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

Colonic polyps Colorectal neoplasms Hyperplastic polyps Sessile serrated lesions

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, Seoul, 05505, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.