NCT07470827Active, not recruiting
Evaluation of 'WAYMED Endo CL CS' for Automated Detection and Diagnosis of Colorectal Adenoma and Non-Adenoma Lesions
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
Source: ClinicalTrials.gov · Last updated 13 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1178 (estimated)
- First submitted
- 9 Mar 2026
- Start date
- 1 Sept 2024
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- WAYCEN Inc
- Diseases
- Colorectal cancer
- NCT number
- NCT07470827
What you commit to
- Study type: Observational
- Planned participants: 1178
- From 1 Sept 2024 to the primary completion date, 1 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Images previously used for training or internal validation of the investigational software.
Other illness
- History of colectomy.
- Diagnosed with inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) or neuroendocrine tumor.
Other
- 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.
Who the study is looking for
- 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).
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yonsei University Gangnam Severance Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.