NCT07744607Completed
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 · Last updated 4 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1114 (actual)
- First submitted
- 29 Jul 2026
- Start date
- Jan 2025
- Primary completion date
- Feb 2025
- Lead sponsor
- Ainex Corporation
- Diseases
- Colorectal cancer
- NCT number
- NCT07744607
What you commit to
- Study type: Observational
- Participants enrolled: 1114
- From Jan 2025 to the primary completion date, Feb 2025
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 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 |
|---|---|---|---|
| Asan Medical Center 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.