Difference in Aerosol-generating Amount Between Wired Magnetic-assisted Capsule Endoscopy System and Esophagogastroduodenoscopy Examination of Varices in Biliary Atresia Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Aerosol-generating Amount
研究概览
简要总结
The goal of this clinical trial is to compare the safeness and effectiveness of traditional esophagogastroduodenoscope (EGD) and wired magnetically assisted capsule endoscopy (MACE) in the diagnosis of esophageal varices in biliary atresia (BA) patients. The main questions it aims to answer are:
- Subjects who do wired magnetically assisted capsule endoscopy do not need to open the mouths during the process, this study also want to know whether wired magnetically assisted capsule endoscopy can reduce the generation of droplets.
- Diagnostic accuracy between traditional esophagogastroduodenoscope and wired magnetically assisted capsule endoscopy in biliary atresia patients with esophageal varices.
Participants will do either traditional esophagogastroduodenoscope or wired magnetically assisted capsule endoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biliary atresia patients > 6 years old
- •Vital signs are stable
- •Without acute gastrointestinal bleeding
排除标准
- •Patients with metal implants, metal stent, artificial joints, bone plates, and bone screw
- •Patients with electronic devices, such as pacemakers, cochlear implants, or other implanted electronic medical devices
- •Throat or esophageal obstruction leading to dysphagia patients
- •Consciousness disturbance patients unable to swallow
- •Patients with acute upper gastrointestinal bleeding
- •Patients with platelet lower than 40K or PT INR > 1.5
研究组 & 干预措施
wired magnetic assisted capsule endoscopy
干预措施: wired magnetic assisted capsule endoscopy (Device)
esophagogastroduodenoscopy
干预措施: esophagogastroduodenoscopy (Device)
结局指标
主要结局
Aerosol-generating Amount
时间窗: 1 day
Aerosol-generating amount were measured using the MET ONE airborne particle counter \[DR-528 Handheld Particle Counter (Met One Instruments, Inc., Grants Pass, OR)\]. The device was placed on a platform at the same horizontal level as the patient lying flat, to capture airborne particles (sizes: 0.3-10 μm).Background environmental values were measured prior to each procedure and subtracted to determine net aerosol generation. Results are expressed as the total number of particles generated.
次要结局
- Particles Generated Per Minute(1 day)
- Number of Participants With Esophageal Varices(1 day)
- Number of Participants With Gastric Varices(1 day)
- Questionnaire Assessments(1 day)
- Examination Time(1 day)
- Completion Rate(1 day)