Implantable Systems Performance Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10,981
- 试验地点
- 2
- 主要终点
- Product Performance
研究概览
简要总结
The Implantable Systems Performance Registry (ISPR) was developed to evaluate the long-term reliability and performance of market-released Medtronic Neuromodulation infusion and stimulation products.
Completion Notice: The ISPR was created by Medtronic to monitor the performance of commercially available products. This registry was initially designed to track performance of Medtronic's implantable infusion and spinal cord stimulation systems beginning in August 2003 and June 2004, respectively. Medtronic DBS Systems were added to the ISPR in June 2009, and Sacral Neuromodulation Systems in April 2010. Medtronic retired the ISPR in April 2016 and merged the data collected from this registry into the Product Surveillance Registry (PSR). Please refer to that record, Clinical Trials identifier: NCT01524276, for further information.
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
- •Scheduled for an implant or replacement with a market-released Medtronic implantable drug pump, spinal cord stimulator, deep brain stimulator, or sacral nerve stimulator
排除标准
- •Patient who is or will be inaccessible for follow-up at an ISPR study site
- •Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study
结局指标
主要结局
Product Performance
时间窗: Annually
To quantify and compare the rates of device-related events for market-released Medtronic Neuromodulation infusion and stimulation devices
次要结局
未报告次要终点