First-in-man Trial of the Magnetic-controlled Balloon Inflation Mechanism of a Novel Ingestible Weightloss Microcapsule
试验速览
- 阶段
- 不适用
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Successful inflation and maintenance of the fully inflated intragastric balloon.
研究概览
简要总结
The objective of this study is to demonstrate the ease of deployment of a novel magnetically-controlled ingestible weight loss microcapsule* and the functionality of the magnetically controlled inflation of the balloon within the stomach.
详细描述
The objective of this study is to demonstrate the ease of deployment of a novel magnetically-controlled ingestible weight loss microcapsule and the functionality of the magnetically controlled inflation of the balloon within the stomach. Device comes in the form of a gelatine coated pill (Ø9.6mm x 27mm) . Once in the stomach, the device may be driven by external magnetic controllers which can control both its position and orientation. It allows flexible approach of the external magnetic fields in any axial directions of the device, and it also controls the inflation valve which controls the inflation of an attached balloon. The inflated balloon will partially fill up the stomach, giving the subject the feel of satiety to reduce his/her desire to eat more food.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Individuals with anatomical abnormalities or functional disorders that may inhibit swallowing or passage through to the stomach
- •Individuals with history or symptoms of clinically significant esophageal or gastric disorders, peptic ulcerations, hiatal hernia, patulous pyloric channel, erosive esophagitis, varices, angiectasia, Barrett's esophagus
- •Individuals with bowel obstruction, congenital or acquired GI anomalies (e.g., atresias, stenosis, stricture, and/or diverticula), severe renal, hepatic, and/or pulmonary disease
- •Individuals with bleeding disorders
- •Individuals already having other bioenteric devices placed
- •Individuals who have pace makers, metal implants or other devices on them
- •Pregnant women
- •Individuals unable to make/sign informed consent
研究组 & 干预措施
Prototype Microcapsule Treatment Arm
Intervention by placement of prototype weight-loss microcapsule in the stomach. Subjects will have a weight-loss microcapsule deployed endoscpically in the stomach. The intragastric balloon in the capsule will be inflated using an external magnet..
干预措施: Prototype Microcapsule Treatment (Device)
结局指标
主要结局
Successful inflation and maintenance of the fully inflated intragastric balloon.
时间窗: 10 minutes
A fully inflated intragastric balloon in the stomach that is maintained for at least 10 minutes.
次要结局
未报告次要终点