Active — Not RecruitingNot Applicable

Evaluation of 'WAYMED Endo CL CS' for Automated Detection and Diagnosis of Colorectal Adenoma and Non-Adenoma Lesions

South Korea1,178 participantsStarted 2024-09-01

Plain-language summary

The purpose of this clinical trial is to evaluate the effectiveness of the computer-aided diagnosis (CADx) software, 'WAYMED endo CL CS', which assists medical specialists by automatically analyzing colorectal endoscopic images, identifying lesions, and providing probability values to classify them as Adenoma or Non-Adenoma. This pivotal trial is designed to confirm that 'WAYMED endo CL CS' can support clinicians in diagnostic decision-making by improving the classification of colorectal lesions.

Who can participate

Age range19 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Adult patients (≥19 years) with colorectal endoscopic images showing one lesion.
✓. Histopathology confirming the lesion as Adenoma (colorectal cancer, adenoma) or Non-Adenoma (sessile serrated lesion, hyperplastic polyp).

Exclusion criteria

✕. Images previously used for training or internal validation of the investigational software.
✕. History of colectomy.
✕. Diagnosed with inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) or neuroendocrine tumor.
✕. Poor image quality (blurred, incomplete lesion capture).
✕. Images with multiple lesions or fewer than two images per lesion.
✕. Determined by the investigator to be inappropriate for inclusion.

What they're measuring

Clinical Sensitivity in classifying colorectal lesions (%)

Timeframe: 6 months

Clinical Specificity in classifying colorectal lesions (%)

Timeframe: 6 months

Trial details

NCT IDNCT07470827

SponsorWAYCEN Inc

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-12-01

View on ClinicalTrials.gov More Colorectal Adenoma trials