Remote-controlled Capsule Endoscopy: a Feasibility Study
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- the percentage of complete visualization of anatomic landmarks
研究概览
简要总结
The present study is a feasibility study to assess the safety and efficacy of wireless capsule endoscope and compare the data obtained with those obtained by using a conventional esophagogastroduodenoscopy.
The product was developed and manufacture in China.(the NaviCam. AKC-1.China)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •upper abdominal symptoms (≥1 year )
- •surveillance gastroscopy for known gastric ulcer or polyps
- •history of gastric ulcer or polyps （≤1w）at Nanfang Hospital were enrolled.
排除标准
- •dysphagia
- •suspected or documented digestive tract malformation ,obstruction, strictures or fistula
- •acute upper GI bleeding, acute enteritis, acute ischemia disease
- •history of abdominal operations
- •impaired renal function, congestive heart failure
- •patients with critical condition or mental illness
- •patients with, known allergy to polymer material or antifoam agent
- •patients with cardiac pacemakers or other implanted electromedical devices，magnetic resonance imaging ( mri) examination in 7 days
- •pregnancy
研究组 & 干预措施
Esophagogastroduodenoscopy（ECG）
n=15
干预措施: magnetic-controlled capsule endoscopy(Navicam) (Device)
结局指标
主要结局
the percentage of complete visualization of anatomic landmarks
时间窗: 2 year
the percentage of patients in whom there was complete visualization of the gastric surface in the antrum, body, and fundus and identification of the cardia and pylorus
examination time and the percentage of abnormal finding
时间窗: 2 year
examination time and the percentage of abnormal findings seen on gastroscopy that were reproducible by capsule endoscopy
次要结局
- adverse effect(2 year)
- Acceptability(2 year)
研究者
xinying wang
Associate Professor
Nanfang Hospital, Southern Medical University