NCT03255200已完成不适用
ReActiv8 Post Market Surveillance Registry for the ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain
Mainstay Medical5 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2017年10月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 5
- 主要终点
- Low Back Pain - Numeric Pain Rating (NRS) Scale
研究概览
简要总结
To gather data on the long-term safety of ReActiv8 and identify any residual risks by reporting all Serious Adverse Device Effects as well as performance and health care utilization through two years post-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
- •Meet the Indications for ReActiv8
- •Willing to sign the Informed Consent for the Registry
- •Age ≥ 18 years
排除标准
- •Subjects will be excluded from the Registry if they are contraindicated for ReActiv8.
结局指标
主要结局
Low Back Pain - Numeric Pain Rating (NRS) Scale
时间窗: 90 days, 180 days, 1 year, 2 years post Activation
Change in low back pain Numerical Rating Scale (NRS) compared to Baseline. The NRS is an 11-point scale where 0 means no pain at all and 10 means worst imaginable pain. Patients were asked to rate their average low back pain in the last 24 hours. Lower scores or reduction in score means an improvement or reduction in pain.
次要结局
- Serious Adverse Device Effects(Through 2 years post Activation)
研究者
研究点 (5)
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