NCT02988713已完成不适用
Study to Characterize the Effects of Programming Spinal Cord Stimulation (SCS) in Patients Undergoing a Boston Scientific (BSC) SCS Temporary Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Patient Comfort
研究概览
简要总结
This is a prospective, multi-center, non-randomized, exploratory, single-arm study characterize the effects of programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial
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
- •Study candidate is undergoing a spinal cord stimulation (SCS) trial of BSC neurostimulation system, 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 BSC neurostimulation system local directions for use (DFU).
研究组 & 干预措施
Spinal cord stimulation
Experimental
Spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial
干预措施: Programming (Device)
结局指标
主要结局
Patient Comfort
时间窗: An estimated average of 7 days post temporary trial procedure
Number of participants reporting comfort level of stimulation sensation as "Very Comfortable" or "Slightly Comfortable"
次要结局
未报告次要终点
研究者
研究点 (2)
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