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

NCT06718725 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 236

Last updated 2024-12-05

No results posted yet for this study

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.

Conditions

  • The Malignant Lesions and Non-malignant Lesions of Pancreas, Bile Duct, Liver and Lymph Node

Interventions

DIAGNOSTIC_TEST

ROSE-AI system

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

Sponsors & Collaborators

  • Taian City Central Hospital

    collaborator OTHER

  • Qilu Hospital of Shandong University (Qingdao)

    collaborator OTHER

  • Shandong Provincial Hospital

    collaborator OTHER_GOV

  • Liaocheng People's Hospital

    collaborator OTHER

  • The Affiliated Hospital of Qingdao University

    collaborator OTHER

  • Binzhou People's Hospital

    collaborator OTHER

  • Binzhou Medical University

    collaborator OTHER

  • 960th Hospital of PLA

    collaborator UNKNOWN

  • Yidu Central Hospital of Weifang

    collaborator UNKNOWN

  • Qilu Hospital of Shandong University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06718725 on ClinicalTrials.gov