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AI tool aims to sharpen colonoscopy diagnoses

NCT ID NCT07470827

Diagnosis Sponsor: WAYCEN Inc 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a computer program that analyzes colonoscopy images to help doctors decide if a growth (polyp) is an adenoma (pre-cancerous) or not. The software gives a probability score for each lesion. The trial involves 1,178 adults and compares the software's results to lab tissue analysis. The goal is to see if the AI can improve diagnostic accuracy.

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 1,178 people

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

Started

Sep 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

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

Colorectal endoscopic images from adult patients (≥19 years) who underwent colonoscopy and biopsy, with confirmed histopathology results for Adenoma or Non-Adenoma lesions.

Ages

19 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: 1. Adult patients (≥19 years) with colorectal endoscopic images showing one lesion. 2. Histopathology confirming the lesion as Adenoma (colorectal cancer, adenoma) or Non-Adenoma (sessile serrated lesion, hyperplastic polyp). Exclusion Criteria: 1. Images previously used for training or internal validation of the investigational software. 2. History of colectomy. 3. Diagnosed with inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) or neuroendocrine tumor. 4. Poor image quality (blurred, incomplete lesion capture). 5. Images with multiple lesions or fewer than two images per lesion. 6. Determined by the investigator to be inappropriate for inclusion.

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Conditions

The condition(s) this trial relates to.

adenoma carcinoma colon sessile serrated adenoma/polyp colorectal adenoma colorectal cancer colorectal sessile serrated adenoma/polyp hyperplastic polyp

As listed by the trial registrant

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

Adenoma Carcinoma Colorectal adenoma Hyperplastic polyp Non-adenoma Sessile serrated lesion

Contacts and locations

Locations

  • Yonsei University Gangnam Severance Hospital

    Seoul, Gangnam, 06273, South Korea

More trials for these conditions

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