New MCE System for Detection of Gastric Lesions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- the degree of gastric mucosal visualization
研究概览
简要总结
Clinical application of magnetically controlled capsule endoscopy : a prospective self-controlled trial
详细描述
The aim of this study is to investigate the effectiveness and safety of using a new MCE system for routine gastric examination and automatic scanning. This study is a prospective, self controlled clinical trail, which includes adult patients who plan to undergo MCE examination. Patients will undergo three different tests during the experiment: NaviEC-2000Pro Gastro Scan, NaviEC-2000Pro routine gastric examination, NaviEC-1000 routine gastric examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •underwent gastric examination;
- •At least 18 years old；
- •Be able to provide informed consent.
排除标准
- •With swallowing obstruction or disorders;
- •With known or suspected gastrointestinal obstruction, stenosis and fistula;
- •Have no conditions for surgery or refuse to undergo any abdominal surgery;
- •Be allergic to or have other known contraindication or intolerance to the drug used in the study;
- •With pacemakers or other electronic devices such as electronic cochlear implants, implanted magnetic metal drug infusion pumps, neurostimulators, and magnetic metal foreign bodies;
- •Women during pregnancy;
- •Currently enrolled in another clinical trial of a drug or device;
- •Other conditions determined by the investigator to be inappropriate for enrollment.
结局指标
主要结局
the degree of gastric mucosal visualization
时间窗: 2 weeks
The overall observational integrity of the gastric mucosa is based on the evaluation of the mucosal visualization of several key anatomical sites in the stomach: cardia, fundus, gastric body, gastric horn, gastric antrum and pylorus. The evaluation criteria for mucosal visualization of each site are: good : adequate observation, ≥90% of the gastric mucosa can be observed; fair : good observation, 70-90% of the gastric mucosa can be observed; poor : inadequate observation, \<70% of the gastric mucosa can be observed.
次要结局
- Safety Assessment(2 weeks)
- detection of lesions(2 weeks)
- The time of gastric examination(2 weeks)
- Equipment operation evaluation(2 weeks)