Clinical Validity Verification on Diagnostic Assistance for Presence and Severity of Colorectal Cancer and Polyps Using Artificial... | NCT07744607

NCT07744607

Overview

NCT ID: NCT07744607
Lead Sponsor: Ainex CorporationINDUSTRY
Official Title: 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
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.
Conditions

Status and Timeline

Status: Completed
Last Update Posted: Aug 4, 2026Actual
Start Date: Jan 20, 2025Actual
Primary Completion Date: Feb 17, 2025Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 1,114Actual
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking

Contacts and Locations

Central Contacts: No data available
Locations: Asan Medical Center

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