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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BlueWind Reprieve System | Experimental | The Reprieve implant will be implanted for eligible patients. Implant parameters settings will be set according to patient's sensations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Reprieve system | Device | BlueWind Medical neurostimulator for the treatment of neuropathic pain |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ron Dabby, MD | Wolfson Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Health care campus | Haifa | 3525408 | Israel | |||
| Edith Wolfson Medical Center |
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| Holon |
| 58100 |
| Israel |