ACTRN12616001304426已完成不适用
A multi-centre, open-label, prospective, feasibility study evaluating the Nalu Alpha External Trial Stimulator for the treatment of chronic pain via Spinal Cord Stimulation (SCS)
alu Medical0 个研究点目标入组 33 人开始时间: 2016年9月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1. Have a minimum or 1 surgical intervention of the lumbar spine
- •2..Have been diagnosed with chronic, intractable pain of the low back and/or legs.
- •3. Have been approved by their doctor to undergo a commercial trial of SCS.
- •4. Be an appropriate candidate for the surgical procedures required in this study.
- •5. Be willing and capable of giving informed consent
- •6. Be willing and able to comply with study-related requirements, procedures, and visits
排除标准
- •1.Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints.
- •2.Are not a surgical candidate due to a diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus
- •3.Have an active systemic or local infection
- •4.Be pregnant or nursing
- •5.Be concomitantly participating in another clinical study
研究者
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