Evaluation of 'WAYMED Endo CL CS' for Automated Detection and Diagnosis of Colorectal Adenoma and Non-Adenoma Lesions
NCT07470827 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1178
Last updated 2026-03-13
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.
Conditions
- Colorectal Adenoma
- Sessile Serrated Lesion
- Hyperplastic Polyp
- Carcinoma
- Adenoma
- Non-Adenoma
Interventions
- DEVICE
-
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).
- OTHER
-
Reference standard review
Colorectal endoscopic images are independently reviewed by expert endoscopists and confirmed with histopathology to establish the reference standard.
Sponsors & Collaborators
-
WAYCEN Inc
lead INDUSTRY
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-01
- Primary Completion
- 2026-12-01
- Completion
- 2026-12-01
Countries
- South Korea
Study Locations
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