Using AI to improve mediastinal ultrasound scans
Validation of an AI-Assisted Mediastinal EUS System for Training Improvement: a Prospective, Multi-Center, Randomized Trial
This study is testing whether using an AI system during mediastinal ultrasound scans can help doctors get better images and improve diagnosis compared to doing it without AI.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The Third Xiangya Hospital of Central South University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT06790108 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to validate the effectiveness of an artificial intelligence (AI) system in assisting mediastinal endoscopic ultrasound (EUS) procedures. It will compare the image recognition accuracy of the AI system against that of trained EUS endoscopists and assess whether the AI can enhance the quality of the scans performed. Participants will undergo EUS with or without the AI assistance to determine its impact on diagnostic outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 79 who require endoscopic ultrasonography.
Not a fit: Patients with severe physical conditions or those who do not consent to participate will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved accuracy and quality in mediastinal ultrasound scans, benefiting patients with mediastinal diseases.
How similar studies have performed: While the use of AI in medical imaging is gaining traction, this specific application in mediastinal EUS is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Changsha, Hunan
- The Third Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)
Study contacts
- Principal investigator: Xiaoyan Wang, Doctor — The Third Xiangya Hospital of Central South University
- Study coordinator: Xiaoyan Wang, Doctor
- Email: wangxiaoyan@csu.edu.cn
- Phone: +8613974889301
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.