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RECRUITING
NCT06718725

An Artificial Intelligence System for ROSE of EUS-FNA Sample: a Prospective, Multicenter, Diagnostic Study.

Sponsor: Qilu Hospital of Shandong University

View on ClinicalTrials.gov

Summary

This is an observational study with a prospective, multicenter, disgnostic design. An artificial intelligence system named ROSE-AI system was developed using cytopathological slide images taken by microscope camera or smartphone of pancreas, bile duct, liver and lymph node, collected retrospectively from patients who underwent EUS-FNA and ROSE, and the performance of ROSE-AI system was validated in the datasets collected prospectively.This study aims to assist endoscopists in conducting rapid on-site cytopathology evaluations during EUS-FNA without the presence of cytopathologists. In addition, the diagnostic field was compared between the cytopathologists and ROSE-AI system, endoscopists with or without ROSE-AI system.

Official title: An Artificial Intelligence System for Rapid Onsite Cytologic Pathology Evaluation(ROSE) of Endoscopic Ultrasound-guided Fine-needle Aspiration (EUS-FNA) Sample: a Prospective, Multicenter, Diagnostic Study.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

236

Start Date

2024-09-01

Completion Date

2026-04

Last Updated

2024-12-05

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

ROSE-AI system

The cytopathological slide images of the patients' ROSE samples will be identified by the ROSE-AI system.

Locations (1)

Qilu Hospital of Shandong University

Jinan, Shandong, China