BlueWind Reprieve System for the Treatment of PNP

Safety and Performance of the BlueWind Medical Reprieve System for the Treatment of Patients With Peripheral Neuropathic Pain

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Neuropathic Pain
• Intervention / Treatment: Device: The Reprieve system

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 3525408
    • Rambam Health Care Campus
  • Holon, Israel, 58100
    • Edith Wolfson Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BlueWind Reprieve System; The Reprieve implant will be implanted for eligible patients. Implant parameters settings will be set according to patient's sensations.	Device: The Reprieve system; BlueWind Medical neurostimulator for the treatment of neuropathic pain

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

Collaborators and Investigators

• Sponsor: BlueWind Medical
• Investigators: Principal Investigator: Ron Dabby, MD, Wolfson Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: August 3, 2014
• First Submitted That Met QC Criteria: August 5, 2014
• First Posted (Estimate): August 6, 2014

Study Record Updates

• Last Update Posted (Actual): April 11, 2018
• Last Update Submitted That Met QC Criteria: April 10, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Peripheral Neuropathic Pain; PNP
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: CP-04-001