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Clinical Trials in China / NCT06790108
Recruiting Not applicable

Validation of an AI-Assisted Mediastinal EUS System for Training Improvement: a Prospective, Multi-Center, Randomized Trial

NCT06790108 · tracked via the Priya Life Science China tracker
Sponsor
The Third Xiangya Hospital of Central South University
Phase
Not applicable
Started
2025-01-15
Last updated
2025-01-23

Condition(s) studied

Mediastinal Disease

Investigational drug(s) / intervention(s)

Artificial intelligence device

Artificial intelligence device: This AI device can provide prompts for standard sites of pancreatic scans and anatomical structures. It may also suggest the next operation methods.

Study summary

The goal of this clinical trial is to verify the auxiliary role of the artificial intelligence (AI) system in mediastinal endoscopic ultrasound (EUS) scans. The main questions it aims to answer are as follows:

1. A comparison of the image recognition accuracy between the AI system and EUS endoscopists.
2. Whether the AI system can improve the quality of mediastinal scans for EUS endoscopists.

Participants will conduct mediastinal EUS with or without the assistance of the AI system.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1\. Age ≥18 years old, \<80 years old 2.Patients who need endoscopic ultrasonography; 3. Agree to participate in this study and sign the informed consent form. Exclusion Criteria: Subjects who meet any of the following criteria cannot be selected for this trial: First. The patient's physical condition does not meet the requirements of conventional endoscopic ultrasonography: Poor physical condition, including hemoglobin ≤8.0g/dl, severe cardiopulmonary insufficiency, etc. Anesthesia assessment failed Pregnancy or breastfeeding In the acute stage of chemical and corrosive injury, it is very easy to cause perforation Recent acute coronary syndrome or clinically unstable ischemic heart attack Heart disease patients with right-to-left shunt, patients with severe pulmonary hypertension (pulmonary artery pressure\> 90mmHg), patients with uncontrolled systemic hypertension and patients with adult respiratory distress syndrome. Second. Disagree to participate in this study. Third. There are other problems that do not meet the requirements of this research or that affect the results of the research: 1. Mediastinal lesions have previously undergone surgery or radiotherapy and chemotherapy; 2. Mental illness, drug addiction, inability to express themselves or other diseases that may affect follow-up.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The Third Xiangya Hospital of Central South University Changsha Hunan Recruiting

More The Third Xiangya Hospital of Central South University trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06790108 on ClinicalTrials.gov ↗ ← All trials in China