NCT01524276招募中不适用
Medtronic Product Surveillance Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Medtronic
- 入组人数
- 100,000
- 试验地点
- 395
- 主要终点
- Safety and Effectiveness of Market Released products
研究概览
简要总结
The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
- •Patient has or is intended to receive or be treated with an eligible Medtronic product
- •Patient within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment
排除标准
- •Patient who is, or will be, inaccessible for follow-up
- •Patient with exclusion criteria required by local law
- •Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
结局指标
主要结局
Safety and Effectiveness of Market Released products
时间窗: Every 6-12 months (Therapy-dependent)
次要结局
未报告次要终点
研究者
研究点 (395)
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