A Retrospective Study to Evaluate the Feasibility and Safety of Magnetically Controlled Capsule Endoscope System in Gastric Examination in Obese People
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- the degree of gastric mucosal visualization
研究概览
简要总结
This retrospective study aimed to evaluate the feasibility and safety of MCE for the detection of gastric disease in obese people.
详细描述
In this study, we evaluated the feasibility and safety of MCE for the detection of gastric disease in obese people by comparing the results of MCE between healthy weight people (18.5≤BMI<25) and obese people (BMI≥30). The observation index included mucosal visualization, gastric transit time, cleanliness of the stomach, detection of lesions and safety evaluation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •18.5≤BMI<25 or BMI≥30
- •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
- the cleanliness of the stomach(2 weeks)
- Gastric distention(2 weeks)
- Stomach transmit time(2 weeks)
- Incidence of adverse events(2 weeks)
- Small bowel transmit time(2 weeks)