A Prospective Randomized Controlled Trial of AI-box , a Real-time Quality Control System of Magnetic-controlled Capsule Gastroscopy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- Mean inspection completeness
研究概览
简要总结
With the rapid development of artificial intelligence technology, more and more deep learning technology has been applied to medicine. Our research is to develop a set of quality control system for magnetic capsule gastroscope using deep learning technology, and conduct a randomized controlled trial to verify its practical efficiency.
详细描述
The accuracy of magnetic controlled capsule endoscopy(MCCE) in the diagnosis of stomach lesions is highly consistent with the traditional electronic gastroscopy. It has become a new comfortable and safe form for screening and It is also the beneficial complementarity of the traditional electronic gastroscope. To ensure the medical quality of magnetic controlled capsule endoscopy system, Based on Artificial Intelligence Deep Learning Technology ,investigators developed the Magnetic-controlled Capsule Endoscopic Assisted Quality Control System(AI-box).Randomized controlled trials will be conducted on prospective subjects to verify the quality control efficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Both participates and outcomes Assesors will be masked
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients aged 18-75 years old who underwent MCCG examination in Qilu Hospital of Shandong University, Shandong Provincial Hospital affilated to Shandong First Medican University, and the Binzhou Medical University Hospital.
排除标准
- •People who are allergic to the ingredients prepared in the stomach before examination;
- •Patients with astrointestinal bleeding or ulcers, or prior gastrointestinal bleeding or ulcers within the last 24 months;
- •Patients with esophageal and gastric tumor diseases that are undergoing active surgical treatment;
- •Contraindications to the MCE test, including suspected or known gastrointestinal obstruction, stenosis, fistula, diverticula, etc; presence of gastrointestinal obstruction symptoms such as pain or dysphagia;
- •Prior gastrointestinal tract or abdominal surgery other than simple procedures which would not change the gastrointestinal tract anatomy, such as polyp removal, cholecystectomy or appendectomy;
- •Inoperative conditions or refusal to undergo abdominal surgery if required (ie, if the capsule will not pass and cannot be removed by endoscopy);
- •A cardiac pacemaker is installed in the body, except when the pacemaker is a new MRE-compatible product;
- •Electronic devices such as cochlear implant, magnetic metal drug infusion pump, nerve stimulator and magnetic metal foreign body are implanted in vivo;
- •Planned MRI examination before capsule endoscopy discharge;
- •Pregnant women;
- •Patients with deglutition disorders or gastric emptizing disorders.
结局指标
主要结局
Mean inspection completeness
时间窗: 4 months
After the inspection，investigators will review the whole process of inspection and record the sites observed as well as unobserved sites，then calculate the inspection completeness（number of observed sites in each patient/10）besides the the blind spot rate(number of unobserved sites in each patient/10 ) per procedure in control group and AI-assisted group.
次要结局
- Cleanliness judgement consistency between expert and AI-box(4 months)
研究者
Yanqing Li
Vice President of Qilu Hospital
Shandong University