Safety and Performance of the BlueWind Medical Reprieve System for the Treatment of Patients With Peripheral Neuropathic Pain (PNP)
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
- 8
- 主要终点
- The Incidence of System and/or Procedure Related Serious Adverse Events (SAEs).
研究概览
简要总结
The current study will evaluate the safety and performance of the BlueWind Medical Reprieve System for the treatment of Chronic Painful Peripheral Neuropathy.
详细描述
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 2-3 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.
结局指标
主要结局
The Incidence of System and/or Procedure Related Serious Adverse Events (SAEs).
时间窗: 6 months
The incidence of system and/or procedure related serious adverse events (SAEs) throughout the entire study period
Pain Assessment by Visual Analogue Scale (VAS) as Compared to Baseline at 6 Months Post Activation
时间窗: 1 Month, 3 Months, and 6 months post system activation
VAS score assessment at baseline and follow up visits was performed in two ways; 1. Pain Diary VAS score- the analysis was based on the pain diary, processing the average daily VAS scores over seven consecutive days. 2. Point VAS score- the analysis was based on the VAS score measurement recorded during the baseline visit and following 30 minutes stimulation at all follow up visits.Pain assessment by Visual Analogue Scale (VAS) as compared to baseline, post system activation. Visual Analogue Scale (VAS) for Pain Scores on a scale \[0 - 10\], higher values represent a worse outcome.
次要结局
- Clinical Success 6 Months Post Activation(1 Month, 3 Months, and 6 months post system activation)