NCT04218292Unknown不适用
Dr. Amplatz Micro Plug - Post Market Clinical Follow-up (PMCF) Plan
KA Medical, LLC1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年3月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Rate of serious device-related and procedure-related adverse events
研究概览
简要总结
This is an observational, post market clinical follow-up (PMCF) intended to evaluate the residual risks of the Micro Plug Set which is intended for use during arterial embolization of the peripheral vasculature. This PMCF will collect data pertaining to any adverse events as well as the identification of any unanticipated risks up to the first 12 months following device implant.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Subject is scheduled for arterial embolization in the peripheral vasculature.
- •Subject is greater than 18 years of age
排除标准
- •Subject is unable to give informed consent
- •Subject is pregnant or breastfeeding
- •Subject has allergy to nickel
- •Patient requires neurologic or cardiac use of an occlusion device, contrary to the Micro Plug Set Instructions For Use.
结局指标
主要结局
Rate of serious device-related and procedure-related adverse events
时间窗: 12 months
Rate of serious device-related and procedure-related adverse events
次要结局
- Rate of successful delivery of the device(1 day)
研究者
研究点 (1)
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