NCT05353777已完成不适用
Clinical Evaluation of the Levita Robotic Platform
Levita Magnetics4 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2021年5月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- Adverse Events Related to the Device
研究概览
简要总结
The purpose of this study is to evaluate the safety and feasibility of the Levita Robotic Platform (LRP) used with the Levita Magnetic Surgical System (MSS)
详细描述
Prospective, multi-center, single-arm, open label study designed to assess the safety and feasibility of the use of the Levita Robotic Platform with the Levita Magnetic Surgical System in laparoscopic 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
- Treatment
- 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
- •• Subject is at least 18 years of age
- •Subject is scheduled to undergo elective laparoscopic procedure
- •Subject signs a written Informed Consent Form (ICF) to participate in the study prior to any study required procedures
排除标准
- •• Subjects with pacemakers, defibrillators, or other electromedical implants
- •Subjects with ferromagnetic implants
- •Subjects with significant comorbidities: cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure)
- •Subjects with a clinical history of impaired coagulation confirmed by abnormal blood tests
- •Subject has an anatomical abnormality or disease of intended target tissue noted after initiation of index procedure that would prevent device use
- •Subject is pregnant or wishes to become pregnant during the length of study participation
- •Subject is not likely to comply with the follow-up evaluation schedule
- •Subject is participating in a clinical trial of another investigational drug or device
结局指标
主要结局
Adverse Events Related to the Device
时间窗: 30 days
Total number of adverse events related to the device.
次要结局
- Rate That the Levita Robotic Platform is Able to Engage, Move, and Decouple With the Magnetic Surgical System as Controlled by the Surgeon(Interoperatively)
- Conversion Rate to Open Surgery(Interoperatively)
研究者
研究点 (4)
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