Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenoma | Adenoma | ONTOLOGY_EXACT | 0.98 |
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Adenoma | Colorectal Adenoma | ONTOLOGY_EXACT | 0.98 |
| Hyperplastic Polyp | — | UNRESOLVED | — |
| Non-Adenoma | — | UNRESOLVED | — |
| Sessile Serrated Lesion | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Reference standard review | Other | — | UNRESOLVED |
| WAYMED endo CL CS | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Trial group
- description
- Colorectal endoscopic images in this group are analyzed by WAYMED endo CL CS, which identifies lesions and classifies them as "Adenoma" or "Non-Adenoma" with probability values.
- interventionNames
- Device: WAYMED endo CL CS
- label
- Reference Standard
- description
- All lesions are verified by histopathology and annotated by the Reference Standard Establishment Committee (experienced endoscopy specialists). This serves as the comparator for evaluating diagnostic performance.
- interventionNames
- Other: Reference standard review
Primary outcomes (2)
- measure
- Clinical Sensitivity in classifying colorectal lesions (%)
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available