NCT06790108 Validation of an AI-Assisted Mediastinal EUS System for Training Improvement: a Prospective, Multi-Center, Randomized Trial
| NCT ID | NCT06790108 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Third Xiangya Hospital of Central South University |
| Condition | Mediastinal Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-01-15 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2025-01-15 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Xiaoyan Wang, Doctor
PRINCIPAL INVESTIGATOR
The Third Xiangya Hospital of Central South University
Frequently Asked Questions
Who can join the NCT06790108 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Mediastinal Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06790108 currently recruiting?
Yes, NCT06790108 is actively recruiting participants. Contact the research team at wangxiaoyan@csu.edu.cn for enrollment information.
Where is the NCT06790108 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT06790108 clinical trial?
NCT06790108 is sponsored by The Third Xiangya Hospital of Central South University. The principal investigator is Xiaoyan Wang, Doctor at The Third Xiangya Hospital of Central South University. The trial plans to enroll 200 participants.