Actively Recruiting
An Artificial Intelligence System for ROSE of EUS-FNA Sample: a Prospective, Multicenter, Diagnostic Study.
Led by Qilu Hospital of Shandong University · Updated on 2024-12-05
236
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
Sponsors
Q
Qilu Hospital of Shandong University
Lead Sponsor
T
Taian City Central Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
An Artificial Intelligence System for ROSE of EUS-FNA Sample: a Prospective, Multicenter, Diagnostic Study.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 years of age or older and has undergone EUS-FNA with ROSE.
- Patient agrees to participate in the research and can provide written informed consent.
You will not qualify if you...
- Uncorrectable coagulopathy (PTT >50 seconds or INR >1.5) or uncorrectable thrombocytopenia (platelet count <50 × 10^9 /L).
- Patient is too clinically ill to undergo an EUS examination.
- Lesions inaccessible for EUS-guided sampling.
- Unsuccessful EUS-FNA such as failure to obtain an adequate specimen, patient intolerance, or intraoperative accidents.
- Patients with unqualified ROSE smear.
- Patients who underwent biopsy during EUS-FNA but did not receive a definitive pathological diagnosis or pathological report.
- Pregnancy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
Research Team
Z
Zhen Li
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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