Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
Healthy Volunteers
NCT06790108

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

Led by The Third Xiangya Hospital of Central South University · Updated on 2025-01-23

200

Participants Needed

1

Research Sites

75 weeks

Total Duration

On this page

Sponsors

T

The Third Xiangya Hospital of Central South University

Lead Sponsor

Z

ZhuZhou Central Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older and younger than 80 years
  • Patients who need endoscopic ultrasonography
  • Agree to participate in this study and sign the informed consent form
Not Eligible

You will not qualify if you...

  • Poor physical condition including hemoglobin less than or equal to 8.0 g/dl or severe cardiopulmonary insufficiency
  • Failed anesthesia assessment
  • Pregnancy or breastfeeding
  • Acute stage of chemical and corrosive injury with high risk of perforation
  • Recent acute coronary syndrome or unstable ischemic heart attack
  • Heart disease with right-to-left shunt or severe pulmonary hypertension (pulmonary artery pressure over 90 mmHg)
  • Uncontrolled systemic hypertension
  • Adult respiratory distress syndrome
  • Refusal to participate in the study
  • Mediastinal lesions previously treated by surgery, radiotherapy, or chemotherapy
  • Mental illness, drug addiction, inability to express themselves, or other diseases that may affect follow-up

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China, 410000

Actively Recruiting

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Research Team

X

Xiaoyan Wang, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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