BlueWind Reprieve System for the Treatment of PNP

Not Applicable

Completed

• Conditions: Peripheral Neuropathic Pain
• Interventions: Device: The Reprieve system

• Registration Number: NCT02209896
• Lead Sponsor: BlueWind Medical

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-03
• Study First Submitted QC: 2014-08-05
• Study First Posted: 2014-08-06
• Study Start: 2014-12
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-10
• Last Update Posted: 2018-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BlueWind Reprieve System	The Reprieve system	The Reprieve implant will be implanted for eligible patients. Implant parameters settings will be set according to patient's sensations.

Primary Outcome Measures

Name	Time	Method
Pain assessment	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	6 months	The incidence of serious adverse events (system and/or procedure related events)

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Rambam Health care campus; 🇮🇱 Haifa, Israel

Edith Wolfson Medical Center; 🇮🇱 Holon, Israel