WAYMED endo CL CS: Classification of colorectal endoscopic images as "Adenoma" or "Non-Adenoma" by WAYMED endo CL CS (Computer-aided diagnosis software for colorectal endoscopy).
Reference standard review: Colorectal endoscopic images are independently reviewed by expert endoscopists and confirmed with histopathology to establish the reference standard.
Study 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.
Eligibility
Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Clinical Sensitivity in classifying colorectal lesions (%) — 6 months The probability of being classified as "Adenoma" among colorectal endoscopic images confirmed as "Adenoma" through histopathology.
Clinical Specificity in classifying colorectal lesions (%) — 6 months The probability of being classified as "Non-Adenoma" among colorectal endoscopic images confirmed as "Non-Adenoma" through histopathology.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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