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NCT06207825

Accuracy of Computer-aided (CADx) System in Real-time Characterization of Colorectal Ulcerative Diseases

Sponsor: Nanfang Hospital, Southern Medical University

View on ClinicalTrials.gov

Summary

The goal of this observational study is to test the diagnostic accuracy of the newly developed CADx system in predicting the histopathology of colorectal ulcers when compared to expert endoscopists. The main question it aims to answer are to demonstrate whether the newly developed CADx system has a high-level diagnostic accuracy in predicting characterization of colorectal ulcerative diseases. It is a multi-center study with two phases. The first retrospective phase is the development and validation of a CADx system by feature extraction from endoscopic photos and videos. The second prospective phase is the evaluation and comparison of the diagnostic accuracy between the CADx system, expert endoscopists and junior endoscopists.

Official title: A Prospective Study to Evaluate the Diagnostic Accuracy of Computer-aided (CADx) System in Real-time Characterization of Colorectal Ulcerative Diseases

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

OBSERVATIONAL

Enrollment

495

Start Date

2024-01

Completion Date

2026-06

Last Updated

2024-01-17

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Test images and videos

A set of test images and videos will be collected prospectively from other subjects, according to the eligibility criteria, followed by random allocation of computer-generated sequence.