BlueWind Medical Reprieve System for the Treatment of PNP

Study Overview
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Brief Summary
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The current study will evaluate the safety and performance of the BlueWind Medical Reprieve System for the treatment of Chronic Painful Peripheral Neuropathy.

Detailed Description
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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.

Official Title
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Safety and Performance of the BlueWind Medical Reprieve System for the Treatment of Patients With Peripheral Neuropathic Pain (PNP)

Conditions
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Peripheral Neuropathy

Intervention / Treatment
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* Device: The Reprieve System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed written informed consent. Male or female aged 18 - 80. 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The Reprieve system implantation<br>The Reprieve implant will be implanted for eligible patients. Implant parameter settings will be set according to patient's sensations. | Device: The Reprieve System<br>* BlueWind Medical neurostimulator for the treatment of neuropathic pain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Incidence of System and/or Procedure Related Serious Adverse Events (SAEs). | The incidence of system and/or procedure related serious adverse events (SAEs) throughout the entire study period | 6 months | 
| Pain Assessment by Visual Analogue Scale (VAS) as Compared to Baseline at 6 Months Post Activation | VAS score assessment at baseline and follow up visits was performed in two ways; Pain Diary VAS score- the analysis was based on the pain diary, processing the average daily VAS scores over seven consecutive days. 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. | 1 Month, 3 Months, and 6 months post system activation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Success 6 Months Post Activation | Clinical success at 6 months post activation was further assessed by:Short-form McGill pain questionnaire. McGill pain questionnaire Scores on a scale Range [0-60] points, higher values represent a worse outcome. | 1 Month, 3 Months, and 6 months post system activation | 
| Clinical Success 6 Months Post Activation | Clinical success is defined as the effect of the BlueWind Reprieve System on the treatment of the following symptoms compared to baseline: - Pain related medication consumption/day | 6 months post activation | 
| Clinical Success 6 Months Post Activation | Clinical success was further assessed by: Quality of life questionnaire (SF-36 Health Survey) SF-36 Health Survey Scores on a scale [0 - 100], higher values represent a better outcome. | 1 Month, 3 Months, and 6 months post system activation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PNP, Stimulation, Peripheral neurostimulation