Clinical trial · Observational
Clinical Validity Verification on Diagnostic Assistance for Presence and Severity of Colorectal Cancer and Polyps Using Artificial Intelligence-based Medical Device Software Endoscopic Imaging Assistance
Clinical Validity Verification on Diagnostic Assistance for Presence and Severity of Colorectal Cancer and Polyps Using Artificial Intelligence-Based Medical Device Software for Endoscopic Imaging Assistance: A Single-Center, Single-Arm, Retrospective, Confirmatory 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)
This completed retrospective study evaluated the clinical performance of ENAD-CADx-01, an artificial intelligence-based medical device software intended to assist healthcare professionals in characterizing colorectal lesions in colonoscopy images. Previously collected colonoscopy images and corresponding histopathological results from Asan Medical Center were analyzed. The performance of ENAD-CADx-01 was evaluated based on its sensitivity, specificity, and overall accuracy in classifying colorectal lesions as neoplasm, hyperplastic polyp, or sessile serrated lesion. No participants were prospectively enrolled, and no study-related intervention was performed.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Polyps | — | UNRESOLVED | — |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Hyperplastic Polyps | — | UNRESOLVED | — |
| Sessile Serrated Lesions | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (6)
- measure
- Clinical Sensitivity for Neoplasm
- timeFrame
- Up to 4 weeks
- measure
- Clinical Specificity for Neoplasm
- timeFrame
- Up to 4 weeks
- measure
- Clinical Sensitivity for Hyperplastic Polyps
- timeFrame
- Up to 4 weeks
- measure
- Clinical Specificity for Hyperplastic Polyps
- timeFrame
- Up to 4 weeks
- measure
- Clinical Sensitivity for Sessile Serrated Lesions
- timeFrame
- Up to 4 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants aged 18 years or older at the time of colonoscopy. * Participants who underwent colonoscopy at Asan Medical Center and had colorectal lesion images available for retrospective analysis. * Participants with corresponding histopathological results available as the reference standard. * Colonoscopy images that met the predefined image quality requirements for analysis by ENAD-CADx-01. Exclusion Criteria: * Participants without corresponding histopathological results for the colorectal lesion. * Images with insufficient quality for analysis, including severe blur, obstruction, or inadequate visualization of the lesion. * Images or records with missing or insufficient data required for the clinical performance analysis. * Lesions that did not meet the predefined target lesion categories or other eligibility requirements specified in the clinical investigation plan.
References
Publications (0)
Data not yet available