Clinical Research Directory
Browse clinical research sites, groups, and studies.
Evaluation of 'WAYMED Endo CL CS' for Automated Detection and Diagnosis of Colorectal Adenoma and Non-Adenoma Lesions
Sponsor: WAYCEN Inc
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.
Official title: The Effectiveness of the Computer-aided Detection/Diagnosis Software, 'WAYMED Endo CL CS', Which Assists Medical Specialists by Automatically Analyzing Colorectal Endoscopic Images With Confirmed Adenoma or Non-Adenoma Lesions, Detecting the Lesion, and Providing Probabilities as to Whether the Lesion Belongs to the Adenoma or Non-Adenoma Group: A Single-center, Single Arm, Retrospective, Superiority, Single-blind, and Pivotal Clinical Trial
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1178
Start Date
2024-09-01
Completion Date
2026-12-01
Last Updated
2026-03-13
Healthy Volunteers
No
Interventions
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.
Locations (1)
Yonsei University Gangnam Severance Hospital
Seoul, Gangnam, South Korea