Prospective Clinical Study of the Levita Magnetics Surgical System Used for Prostatectomy Surgery
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 Tools Required to Retract the Prostate 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 prostatectomy surgery.
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 prostatectomy surgery.
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
- Male
- 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 prostatectomy surgery
排除标准
- •Significant comorbidities
- •Subjects with pacemakers, defibrillators, or other electromedical implants
- •Subjects with ferromagnetic implants
- •Clinical history of impaired coagulation
- •Subject has an anatomical abnormality noted after initiation of index procedure that would prevent device use
- •Subject is not likely to comply with the follow-up evaluation schedule
- •Subject is participating in another clinical trial
结局指标
主要结局
Number of Tools Required to Retract the Prostate During Procedure
时间窗: During planned prostatectomy procudure
Ability to adequately retract the prostate to achieve an effective exposure of the target tissue. Adequate retraction is achieved if it is not necessary to replace the Levita Magnetic Surgical System with another instrument to retract the prostate during the procedure.
Incidence of Device Related Adverse Events (Safety)
时间窗: Through 30 days post prostatectomy 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