A Prospective, Multicenter, Single-arm Study Examining the Assisted Programming Module (APM) in the Evoke Spinal Cord Stimulation (SCS) System to Program Patients With Chronic Pain of the Trunk and/or Limbs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Succsessful Use of APM
研究概览
简要总结
Study to evaluate the use of the Assisted Programming Module (APM) in the Evoke Spinal Cord Stimulation (SCS) System to program patients with chronic pain of the trunk and/or limbs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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 has or is planning to undergo a temporary trial with Evoke System within the FDA approved indication.
- •Subject is willing and capable of giving informed consent and able to comply with study-related requirements.
排除标准
- •There are no exclusion criteria.
研究组 & 干预措施
APM
Investigational programming software module, the Assisted Programming Module (APM)
干预措施: Evoke Spinal Cord Stimulation System (Device)
结局指标
主要结局
Succsessful Use of APM
时间窗: All timepoints through study completion, on average 3-months post-implant procedure.
Of all APM uses, the workflow was able to generate a closed-loop program 134 (96%) times.
Change in Evoked Compound Action Potentials (ECAPs) measured in µV by the Evoke SCS System
时间窗: end of trial period; 1 month and 3 months post-implant
Change in Evoked Compound Action Potentials (ECAPs) measured in µV by the Evoke SCS System
Change in programming parameters (e.g., stimulation frequency [Hz], pulse width [µs], amplitude [mA]) measured by the Evoke SCS System
时间窗: end of trial period; 1 month and 3 months post-implant
Change in programming parameters (e.g., stimulation frequency \[Hz\], pulse width \[µs\], amplitude \[mA\]) measured by the Evoke SCS System
次要结局
- Time to Generate APM Program When Closed-loop Program Achieved(All uses through study completion in which APM was initiated)