NCT02492880已完成不适用
Study to Characterize the Effects of Programming Features of the Boston Scientific Precision Spectra™ Spinal Cord Stimulator System Using the CoverEdge™ Surgical Leads
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Change in Paresthesia Distribution From Subject Completed Paresthesia Drawing Questionnaire
研究概览
简要总结
This is a prospective, on-label, multi-center, non-randomized, exploratory, single-arm study to characterize the effects of programming features of the Boston Scientific Precision Spectra™ Spinal Cord Stimulator (SCS) System using the CoverEdge™ surgical lead.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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 implanted, on-label, with a commercially approved Boston Scientific Spectra neurostimulation system and at least one CoverEdge or CoverEdge X surgical lead, per local directions for use (DFU).
- •Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form.
- •Subject is 18 years of age or older when written informed consent is obtained.
排除标准
- •Subject meets any contraindication in Boston Scientific (BSC) neurostimulation system local DFU.
- •Subject is currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments.
结局指标
主要结局
Change in Paresthesia Distribution From Subject Completed Paresthesia Drawing Questionnaire
时间窗: minimum 25 days post IPG implant
Change in paresthesia distribution based on programming parameters
次要结局
未报告次要终点
研究者
研究点 (4)
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