Safety and Performance of the BlueWind Medical Reprieve System for the Treatment of Patients With Peripheral Neuropathic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 4
- 主要终点
- Pain assessment
研究概览
简要总结
The BlueWind Reprieve system is a neurostimulator consisting of an Implant and external components.
The system is intended for home care use. The chronic pain treatment is achieved by an electrical stimulation of peripheral nerve fibers. The stimulation is set so that it generates paresthesia in the stimulated area (e.g. foot), reducing the pain sensation and improving the quality of life for the patient.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent.
- •Male or female aged 18 -
- •Patient agrees to attend all follow-up evaluations and is willing to completely and accurately fill out pain questionnaires.
- •Diagnosis of chronic neuropathic pain due to peripheral neuropathy.
- •Documented pain attributed to neuropathy for at least 6 months.
- •Pain intensity with an average daily VAS score of at least 6, demonstrated by 3 ratings per day across 7 days.
- •Patient refractory to conservative treatments including pain medication, for at least 6 months.
- •Stable pain medication for at least 4 weeks prior to study enrollment.
排除标准
- •Previous participation in another study with any investigational drug or device within the past 90 days.
- •Any active implant (cardiac or other).
- •Any metal implant in the area of BlueWind device implantation site.
- •Current pregnancy or attempting to get pregnant (female patient).
- •Any clinically significant neurologic disorders (except PNP).- Any clinically significant or unstable medical or psychiatric condition that would affect the patient's ability to participate in the study.
- •Patients with severe or unstable cardiovascular, pulmonary, gastrointestinal, hematological, hepatic, renal or endocrine diseases.
- •Severe peripheral vascular disease that may cause intermittent claudication or ischemic ulcers.
研究组 & 干预措施
BlueWind Reprieve System
The Reprieve implant will be implanted for eligible patients. Implant parameters settings will be set according to patient's sensations.
干预措施: The Reprieve system (Device)
结局指标
主要结局
Pain assessment
时间窗: 6 months post system activation
Pain assessment by Visual Analogue Scale (VAS) as compared to baseline at 6 months post activation
The incidence of serious adverse events
时间窗: 6 months
The incidence of serious adverse events (system and/or procedure related events)
次要结局
- Clinical success defined as the effect of the Reprieve System on patient's symptoms(6 months post system activation)