Product Surveillance Registry (PSR) - Nerve Integrity Monitoring (NIM) Vital Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Medtronic
- 入组人数
- 205
- 试验地点
- 1
- 主要终点
- Adverse Event Rate
研究概览
简要总结
The purpose of this study is to confirm clinical safety and performance of Medtronic's NIM Vital™ System and accessories when used as intended in a real-world setting.
详细描述
Ongoing clinical investigation for the purpose(s) of:
- Providing continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products for their intended use
- Obtaining real-world performance and safety information from a global network of hospitals, clinics, and clinicians intended to represent the range of clinical environments in which Medtronic products are used
- Supporting post-market surveillance activities and post-approval studies that are initiated by Medtronic, regulated by local governments, or are conducted to fulfill government and/ or regulatory authority requests
- Obtaining clinical evidence to guide the development and improvement of medical devices, therapies, device guidelines, and patient services/solutions
- Providing clinical data to support health economics and clinical outcomes research
Enrollment for this study is ambispective, and subjects can be enrolled up to 60 days before or after the baseline procedure. There is no scheduled follow-up visit, however, if a reportable event occurs, patients will be followed until resolution or up to 6 months following the procedure. Total duration for study participants is anticipated to be 1 visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Patient or legally authorized representative (LAR) provides 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 is consented within the enrollment window of the therapy received, as applicable
排除标准
- •Patient who is, or is expected to be, inaccessible for follow-up
- •Participation is excluded by local law
- •Patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound the PSR results
结局指标
主要结局
Adverse Event Rate
时间窗: From enrollment to resolution of AE, or up to 6months following baseline procedure.
Rate of adverse events caused directly by the NIM Vital™ System and/or accessories by determination and quantification of safety related complications.
次要结局
- Device Performance(During baseline procedure)