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
Completed
Conditions studied: Colorectal Neoplasms, Colonic Polyps, Hyperplastic Polyps, Sessile Serrated Lesions
In brief
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.
Key facts
- Study ID
- NCT07744607
- Run by
- Ainex Corporation
- People needed
- 1114
- Starts
- 2025-01-20
- Expected to finish
- 2025-02-17
- Last updated by the study team
- 2026-08-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Asan Medical Center — Seoul, Seoul, South Korea
Full record on ClinicalTrials.gov
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