NCT04627974进行中（未招募）不适用
A Prospective Study to Evaluate the Long-term Effectiveness, Safety, and Performance of the Saluda Medical's EvokeTM Closed-Loop Spinal Cord Stimulation System to Treat Patients With Chronic Pain of the Trunk and/or Limbs
Saluda Medical Pty Ltd16 个研究点 分布在 4 个国家目标入组 70 人开始时间: 2020年8月5日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
- 试验地点
- 16
- 主要终点
- Percent Change in Visual Analogue Scale (VAS) Pain
研究概览
简要总结
The objective of this multicountry, multicentre, prospective study is to evaluate the long-term clinical effectiveness, safety, and performance of the Evoke System in the treatment of chronic pain of the trunk and/or limbs in a real-world population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible for therapy according to the Evoke System indications for use statement and labelling requirements
- •Willing and capable of giving informed consent and able to comply with study-related requirements, procedures, and visits
- •Baseline VAS pain rating ≥60 mm in the primary area of pain
排除标准
- •No further exclusion criteria
研究组 & 干预措施
ECAP-controlled, closed-loop SCS
Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude
干预措施: Evoke Spinal Cord Stimulation (SCS) System (Device)
结局指标
主要结局
Percent Change in Visual Analogue Scale (VAS) Pain
时间窗: 3-months post-implant
Visual Analogue Scale (VAS) to rate pain intensity (0mm \[no pain\] to 100mm \[worst pain imaginable\])
次要结局
- Incidence of device- and procedure-related adverse events(through 60-months post-implant)
- Measurement of ECAPs by the Evoke SCS System(through 60-months post-implant)
研究者
研究点 (16)
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