Prospective, Multi-center, Single-arm, Open Label Study Designed to Assess the Safety and Feasibility of Liver Retraction With the Levita Magnetic Surgical System: Extended Magnetic Grasper Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Device Related Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm.
详细描述
The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System Version 2 in patients undergoing bariatric and/or hiatal hernia 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 elective bariatric and/or hiatal hernia procedures.
- •Willing and able to provide a written Informed Consent Form (ICF) to participate in the study prior to any study required procedures.
排除标准
- •Individuals with pacemakers, defibrillators, or other electromedical implants.
- •Individuals with ferromagnetic implants.
- •American Society of Anesthesiologists (ASA) score of III or IV.
- •Significant comorbidities: cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure).
- •Clinical history of impaired coagulation confirmed by abnormal blood tests.
- •Individuals has signs of hepatic abnormality (e.g.: cirrhosis, liver failure, increase in liver enzymes, etc.).
- •Anatomical abnormality or disease of intended target tissue noted after initiation of index procedure that would prevent device use.
- •Pregnant or wishes to become pregnant during the length of study participation.
- •Individual is not likely to comply with the follow-up evaluation schedule.
- •Participating in a clinical trial of another investigational drug or device.
- •Prisoner or under incarceration.
结局指标
主要结局
Number of Device Related Adverse Events
时间窗: 30 days
All adverse events will be captured and reported. Adverse events will be summarized by relatedness to the device and/or procedure, seriousness and level of severity.
Mobilization Requiring Additional Retractors
时间窗: 1 day
Ability to adequately mobilize the liver to achieve an effective exposure of the target tissue. Adequate mobilization is not achieved if it is necessary to use another liver retractor during the procedure.
次要结局
未报告次要终点