Real-Time Identification of Gastric Lesions and Anatomical Landmarks During Magnetically Controlled Capsule Endoscopy Using Artificial Intelligence
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Sensitivity
研究概览
简要总结
The aim of this study is to evaluate the performance of real-time auxiliary system based on artificial intelligence algorithm in lesion detection and quality control in magnetically controlled capsule endoscopy.
详细描述
Magnetically controlled capsule endoscopy (MCE) has been used in clinical practice for gastric examination, with high sensitivity and specificity of 90.4% and 94.7%, respectively.
Therefore, a real-time auxiliary system based on convolutional neural network deep learning framework was developed to assist clinicians to improve the quality in MCE examinations.
Patients referred for magnetically controlled capsule endoscopy (MCE) in the participating center were prospectively enrolled. After passage through the esophagus, physician will finish the gastric examination under magnetic steering with the real-time auxiliary system. Professional operators guarantee the integrity of the examination and the diagnostic results of professional endoscopist was used as the gold standard. The system diagnosis results was recorded at the same time. The sensitivity, delay time, specificity of lesions and anatomical landmarks will be analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •With or without gastrointestinal complaints
- •Scheduled to undergo a capsule endoscopy for both stomach and small bowel
- •Signed the informed consents before joining this study
排除标准
- •Dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, overt gastrointestinal bleeding, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy
- •Refused abdominal surgery to take out the capsule in case of capsule retention
- •Implanted pacemaker, except the pacemaker is compatible with MRI
- •Other implanted electromedical devices or magnetic metal foreign bodies
- •Pregnancy or suspected pregnancy
结局指标
主要结局
Sensitivity
时间窗: up to 2 weeks
The sensitivity of lesions detected by system
次要结局
- Delay time(up to 2 weeks)
- Specificity(up to 2 weeks)
- Accuracy of anatomic landmarks identification(up to 2 weeks)
- Completeness of real-time observation with assistance(up to 2 weeks)
- Accuracy of heat map(up to 2 weeks)
- Lesion detection yield(up to 2 weeks)