Prospective Study of Liver Mobilization With the Levita Magnetic Surgical System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Number and Types of Additional Tools Required to Mobilize the Liver During Procedure
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing bariatric procedures
详细描述
Prospective, multicenter, single-arm, open label study designed to assess the safety and effectiveness of the Levita Magnetic Surgical System in bariatric procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 18 years of age
- •scheduled to undergo bariatric procedure
排除标准
- •Am Soc Anesthesiology score of III or IV
- •significant comorbidities
- •subjects contraindicated for use of magnetic system
- •clinical history of impaired coagulation
- •hepatic abnormality or anatomical abnormality
结局指标
主要结局
Number and Types of Additional Tools Required to Mobilize the Liver During Procedure
时间窗: During planned bariatric procedure. (approximately 2 hours on a single day.)
The ability to mobilize the liver will be evaluated by recording the number and types of additional tools used to mobilize the liver during a bariatric procedure. If another tool besides the Magnetic Surgical System (MSS) is required to move the liver then the use of the MSS has not been successful.
Number of Participants With Adverse Events and Device Related Adverse Events
时间窗: Through 30 days post bariatric procedure
All adverse events will be recorded and allocated as to relatedness to device, procedure or other.
次要结局
未报告次要终点