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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07744607

Enrollment

1114

Registered

2026-08-04

Start date

2025-01-20

Completion date

2025-02-17

Last updated

2026-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Polyps, Colorectal Neoplasms, Hyperplastic Polyps, Sessile Serrated Lesions

Keywords

Computer-Aided Diagnosis, Artificial Intelligence, Colonoscopy, Colorectal Lesion Characterization, Medical Device Software

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Clinical Sensitivity for Neoplasm	Up to 4 weeks
Clinical Specificity for Neoplasm	Up to 4 weeks
Clinical Sensitivity for Hyperplastic Polyps	Up to 4 weeks
Clinical Specificity for Hyperplastic Polyps	Up to 4 weeks
Clinical Sensitivity for Sessile Serrated Lesions	Up to 4 weeks
Clinical Specificity for Sessile Serrated Lesions	Up to 4 weeks

Countries

South Korea

Outcome results