Actively Recruiting
Validation of an AI-Assisted Mediastinal Endoscopic Ultrasound System for Training Improvement in Mediastinal Disease A Prospective, Multi-Center, Randomized Clinical 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
This clinical trial focuses on mediastinal disease and aims to evaluate how well an artificial intelligence (AI) system assists during mediastinal endoscopic ultrasound (EUS) scans. Researchers want to compare the AI system's image recognition accuracy with that of EUS endoscopists and see if using AI can improve the quality of mediastinal scans performed by the endoscopists. The trial is designed as a prospective, multi-center, randomized study to assess the AI's supportive role. Participants will undergo mediastinal EUS scans either with or without the help of the AI device. This AI tool provides guidance by identifying standard sites in pancreatic scans and anatomical structures, and it may also recommend the next steps during the procedure. The intervention focuses on how the AI device aids the training and performance of EUS endoscopists during their scans. During the study, researchers will monitor how completely standard scanning stations are covered over one year. Participants will be assessed through their EUS procedures, and the quality of scans will be compared between groups using and not using the AI system. The overall participation involves following the scanning process and evaluating the impact of AI assistance on scan completeness and accuracy.
CONDITIONS
Official Title
Validation of an AI-Assisted Mediastinal EUS System for Training Improvement: a Prospective, Multi-Center, Randomized Trial
Who Can Participate
Eligibility Criteria
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
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
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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
Research Team
X
Xiaoyan Wang, Doctor
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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