Validation of an AI-Assisted Mediastinal EUS System for Training Improvement: a Prospective, Multi-Center, Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The completeness for standard station scanning
研究概览
简要总结
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:
- A comparison of the image recognition accuracy between the AI system and EUS endoscopists.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years old, <80 years old 2.Patients who need endoscopic ultrasonography;
- •Agree to participate in this study and sign the informed consent form.
排除标准
- •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:
- •Mediastinal lesions have previously undergone surgery or radiotherapy and chemotherapy;
- •Mental illness, drug addiction, inability to express themselves or other diseases that may affect follow-up.
研究组 & 干预措施
AI-assisted group
Endoscopists perform scans with the assistance of AI device.
干预措施: Artificial intelligence device (Device)
Control group
Endoscopists perform scans without the assistance of AI device.
干预措施: Artificial intelligence device (Device)
结局指标
主要结局
The completeness for standard station scanning
时间窗: 1 year
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.
次要结局
- The completeness of anatomical structure scanning(1 year)
- Procedure time(1 year)
- The incidence of adverse events(1 year)