Skip to main content
OpenTrials
Completed

NCT Number: NCT07744607

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colorectal Neoplasms Colonic Diseases Colonic Polyps Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Hyperplastic Polyps Intestinal Diseases Intestinal Neoplasms Intestinal Polyps Neoplasms Neoplasms by Site Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Rectal Diseases Sessile Serrated Lesions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Center

Seoul, 05505, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Clinical Sensitivity for Neoplasm

    Time frame: Up to 4 weeks

  2. Clinical Specificity for Neoplasm

    Time frame: Up to 4 weeks

  3. Clinical Sensitivity for Hyperplastic Polyps

    Time frame: Up to 4 weeks

  4. Clinical Specificity for Hyperplastic Polyps

    Time frame: Up to 4 weeks

  5. Clinical Sensitivity for Sessile Serrated Lesions

    Time frame: Up to 4 weeks

  6. Clinical Specificity for Sessile Serrated Lesions

    Time frame: Up to 4 weeks

Sponsors and collaborators

Lead sponsor

Ainex Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.