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

Study acronym: ROSE，EUS-FNA
StatusUnknown
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 5, 2024 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06718725
Lead Sponsor Qilu Hospital of Shandong University
Collaborators: Taian City Central Hospital, Qilu Hospital of Shandong University (Qingdao), Shandong Provincial Hospital, Liaocheng People's Hospital, The Affiliated Hospital of Qingdao University, Binzhou People's Hospital, Binzhou Medical University, 960th Hospital of PLA, Weifang Yidu Central Hospital
Conditions
(from sponsor)		 The Malignant Lesions and Non-malignant Lesions of Pancreas, Bile Duct, Liver and Lymph Node
Enrollment 236 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov