Non-contact Endoscopy at Covid-19 Outbreak
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Technical success
研究概览
简要总结
The COVID-19 outbreak and spread throughout the world now constitutes a global public health emergency. Direct contact between doctors and patients in daily practice bears potential risk of Covid-19 infection, and telemedicine, or non-contact medicine, in this circumstance, offers an ideal solution. Remote controlling capsule endoscopy system for gastric examination was recently developed and applicated in clinical practice.
详细描述
The novel non-contact magnetically-controlled capsule endoscopy (MCE) system (Ankon Technologies, China) adds a remote control workstation and a audio-visual exchange system to the original well-establish MCE system, which consists of a robotic magnetic arm, a workstation (now bypassed) and a capsule endoscope, and boasts a 90% sensitivity and 94% specificity for diagnosing gastric focal lesions. This feasibility study aims to evaluate the technical success, clinical success and adverse events of the first clinical application of non-contact MCE system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Signed the informed consents before joining this study
排除标准
- •Dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, 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
Technical success
时间窗: During the procedure
Maneuvarability of the remote control MCE system
次要结局
- Adverse events(During and within 2 weeks after the procedure)
- Clinical success(During the procedure)
研究者
Zhuan Liao
Principal Investigator
Changhai Hospital