Status:
COMPLETED
BlueWind Reprieve System for the Treatment of PNP
Lead Sponsor:
BlueWind Medical
Conditions:
Peripheral Neuropathic Pain
Eligibility:
All Genders
18-80 years
Phase:
NA
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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT02209896
Start Date
December 1 2014
End Date
March 1 2017
Last Update
April 11 2018
Active Locations (2)
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1
Rambam Health care campus
Haifa, Israel, 3525408
2
Edith Wolfson Medical Center
Holon, Israel, 58100