Back to resultsBlueWind Reprieve System for the Treatment of PNP
Primary Purpose
Peripheral Neuropathic Pain
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
The Reprieve system
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Neuropathic Pain focused on measuring Peripheral Neuropathic Pain, PNP
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.
Sites / Locations
- Rambam Health care campus
- Edith Wolfson Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BlueWind Reprieve System
Arm Description
The Reprieve implant will be implanted for eligible patients. Implant parameters settings will be set according to patient's sensations.
Outcomes
Primary Outcome Measures
The incidence of serious adverse events
The incidence of serious adverse events (system and/or procedure related events)
Pain assessment
Pain assessment by Visual Analogue Scale (VAS) as compared to baseline at 6 months post activation
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02209896
Brief Title
BlueWind Reprieve System for the Treatment of PNP
Official Title
Safety and Performance of the BlueWind Medical Reprieve System for the Treatment of Patients With Peripheral Neuropathic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BlueWind Medical
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathic Pain
Keywords
Peripheral Neuropathic Pain, PNP
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BlueWind Reprieve System
Arm Type
Experimental
Arm Description
The Reprieve implant will be implanted for eligible patients. Implant parameters settings will be set according to patient's sensations.
Intervention Type
Device
Intervention Name(s)
The Reprieve system
Intervention Description
BlueWind Medical neurostimulator for the treatment of neuropathic pain
Primary Outcome Measure Information:
Title
The incidence of serious adverse events
Description
The incidence of serious adverse events (system and/or procedure related events)
Time Frame
6 months
Title
Pain assessment
Description
Pain assessment by Visual Analogue Scale (VAS) as compared to baseline at 6 months post activation
Time Frame
6 months post system activation
Secondary Outcome Measure Information:
Title
Clinical success defined as the effect of the Reprieve System on patient's symptoms
Description
Measurements include:
SF-McGill pain Questionnaire Pain related medication consumption/day Quality of life questionnaire SF-36 Health survey and safety
Time Frame
6 months post system activation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron Dabby, MD
Organizational Affiliation
Wolfson Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Health care campus
City
Haifa
ZIP/Postal Code
3525408
Country
Israel
Facility Name
Edith Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
BlueWind Reprieve System for the Treatment of PNP
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