An interventional study of Artificial intelligence device in Mediastinal Disease, sponsored by The Third Xiangya Hospital of Central South University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-23.
Sponsored by The Third Xiangya Hospital of Central South University · Not applicable, Interventional, and Diagnostic
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:
Participants will conduct mediastinal EUS with or without the assistance of the AI system.
The Third Xiangya Hospital of Central South University is the lead sponsor of 95 studies on the registry; 49 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Endoscopists perform scans with the assistance of AI device.
Device: Artificial intelligence device
Endoscopists perform scans without the assistance of AI device.
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.
The completeness for standard station scanning
The primary outcome measure was the completeness for standard station scanning of EUS by endoscopists in the two groups. This was calculated as the number of stations successfully scanned divided by the total number of stations that should have been scanned.
Time frame: 1 year
The completeness of anatomical structure scanning
It calculated as the number of anatomical structures successfully scanned divided by the total number of structures that should have been scanned.
Time frame: 1 year
Procedure time
It defined as the observation time only, excluding the time spent on puncture, elastography, contrast-enhanced ultrasound, or other lesion observation or treatment.
Time frame: 1 year
The incidence of adverse events
The incidence of adverse events in both groups during the entire research process.
Time frame: 1 year
Plan to share: No — Some data underlying this trial cannot be shared publicly due to protection of participant's privacy.
No publications or documents are linked to this record.
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Mediastinal Diseases
The Third Xiangya Hospital of Central South University