Embolization Procedures in the Peripheral Vasculature Using the Magellan™ Robotic System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Evaluation of Safety and Clinical Performance of the Magellan Robotic system with the 6 Fr Catheter. (incidence and description of reported Magellan System device related or contributed adverse events and device deficiencies)
研究概览
简要总结
The purpose of this prospective study is to gather procedural use and safety data on the initial use of the Magellan Robotic System with the Magellan Robotic Catheter 6 Fr, Vascular Accessories 6 Fr and Microcatheter Driver This study will focus on, but not be limited to, endovascular embolization procedures in the peripheral vascular, for example, embolization of the splenic and hepatic arteries, uterine arterial embolization (UAE), prostatic arterial embolization (PAE), and trans-arterial chemoembolization (TACE).
The data will be analyzed for medical education, societal presentation and/or publication by the investigator.
详细描述
The primary objectives of this study are to evaluate the safety and clinical performance of the Magellan Robotic System with the 6 Fr catheter, Vascular Accessories 6 Fr and Microcatheter Driver in patients who are indicated for an embolization procedure or other endovascular procedure in the peripheral vasculature.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Able and willing to provide written informed consent
- •Eligible for an embolization procedure or other endovascular procedure in the peripheral vasculature
- •Not participating in an investigational study involving the peripheral vasculature
排除标准
- •Vasculature cannot accommodate the Magellan Robotic Catheter or required accessories
- •The required delivery of therapeutic device(s) "through" the Magellan Robotic Catheter in which the diameter for the therapeutic device(s) is/are incompatible with the Magellan Robotic Catheter
- •An endovascular approach to the treatment of peripheral vasculature disease is contraindicated
- •Major coagulation abnormalities
- •Presence of significant co-morbid illness that contraindicates surgery or an interventional radiological procedure
- •Unmanageable contrast agent hypersensitivity
- •Patients who are prisoners
- •Patients who are mentally incapacitated, e.g., comatose, unresponsive, cannot provide informed consent, or are deemed unreliable or unstable by the investigator or with a cognitive impairment
- •Pregnant or breastfeeding
结局指标
主要结局
Evaluation of Safety and Clinical Performance of the Magellan Robotic system with the 6 Fr Catheter. (incidence and description of reported Magellan System device related or contributed adverse events and device deficiencies)
时间窗: 2 Days
The primary performance endpoint is device success defined as successful cannulation of the target blood vessel with the Magellan Robotic Catheter 6 Fr, Vascular Accessories 6 Fr and Microcatheter Driver on the first attempt, then accurate delivery of therapy. The primary safety endpoint is the incidence and description of reported Magellan System device related or contributed adverse events and device deficiencies through the study period.
Device success (Successful cannulation of the target blood vessel with the Magellan Robotic Catheter 6 Fr, Vascular Accessories 6 Fr and Microcatheter Driver on the first attempt, the accurate delivery of Therapy)
时间窗: 2 Days
Successful cannulation of the target blood vessel with the Magellan Robotic Catheter 6 Fr, Vascular Accessories 6 Fr and Microcatheter Driver on the first attempt, the accurate delivery of Therapy
次要结局
- Number of Participation with Adverse Events(30 days)