BlueWind Reprieve System for the Treatment of PNP

Study Overview
=================
Brief Summary
-----------------
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
-----------------
Safety and Performance of the BlueWind Medical Reprieve System for the Treatment of Patients With Peripheral Neuropathic Pain

Conditions
-----------------
Peripheral Neuropathic Pain

Intervention / Treatment
-----------------
* Device: The Reprieve system


Participation Criteria
=================
Eligibility Criteria
-----------------
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 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
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BlueWind Reprieve System<br>The Reprieve implant will be implanted for eligible patients. Implant parameters 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?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of serious adverse events | The incidence of serious adverse events (system and/or procedure related events) | 6 months | 
| Pain assessment | Pain assessment by Visual Analogue Scale (VAS) as compared to baseline at 6 months post activation | 6 months post system activation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success defined as the effect of the Reprieve System on patient's symptoms | Measurements include: SF-McGill pain Questionnaire Pain related medication consumption/day Quality of life questionnaire SF-36 Health survey and safety | 6 months post system activation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peripheral Neuropathic Pain, PNP