NCT04662905招募中不适用
A Prospective, Multicentre, Single-arm Feasibility Study Examining Novel Treatment Delivery of the Evoke Spinal Cord Stimulator (SCS) System to Treat Patients With Chronic Pain of the Trunk and/or Limbs
Saluda Medical Pty Ltd47 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年12月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 47
- 主要终点
- Change in Evoke Compound Action Potentials (ECAPs) as measured by the Evoke SCS System
研究概览
简要总结
The purpose of this study is to test and evaluate novel treatment delivery of ECAP-controlled closed loop SCS through the incorporation of new software and/or hardware features for patients with the Evoke System.
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
- •1. Subject has undergone trial implant or is planning to be implanted with the Evoke System within its approved indication.
- •2. Subject is willing and capable of giving informed consent and able to comply with study-related requirements.
排除标准
- 未提供
研究组 & 干预措施
ECAP-controlled, closed-loop SCS
Experimental
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
Change in Evoke Compound Action Potentials (ECAPs) as measured by the Evoke SCS System
时间窗: Through study completion, up to 2 years
次要结局
未报告次要终点
研究者
研究点 (47)
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