Overview

This trial is active, not recruiting.

Condition peripheral neuropathy
Treatment the reprieve system
Sponsor BlueWind Medical
Start date May 2014
End date December 2015
Trial size 20 participants
Trial identifier NCT02062398, CP-02-001

Summary

The current study will evaluate the safety and performance of the BlueWind Medical Reprieve System for the treatment of Chronic Painful Peripheral Neuropathy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
The Reprieve implant will be implanted for eligible patients. Implant parameter settings will be set according to patient's sensations.
the reprieve system
BlueWind Medical neurostimulator for the treatment of neuropathic pain

Primary Outcomes

Measure
The incidence of serious adverse events
time frame: 6 months
Pain assessment
time frame: 6 months post system activation

Secondary Outcomes

Measure
Clinical success defined as the effect of the Reprieve System on patient's symptoms
time frame: 6 months post system activation

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: 1. Signed written informed consent. 2. Male or female aged 18 - 80. 3. Patient agrees to attend all follow-up evaluations and is willing to completely and accurately fill out pain questionnaires. 4. Diagnosis of chronic neuropathic pain due to peripheral neuropathy. 5. Documented pain attributed to neuropathy for at least 6 months. 6. Pain intensity with an average daily VAS score of at least 6, demonstrated by 2-3 ratings per day across 7 days. 7. Patient refractory to conservative treatments including pain medication, for at least 6 months. 8. Stable pain medication for at least 4 weeks prior to study enrollment. Exclusion Criteria: 1. Previous participation in another study with any investigational drug or device within the past 90 days. 2. Any active implant (cardiac or other). 3. Any metal implant in the area of BlueWind device implantation site. 4. Current pregnancy or attempting to get pregnant (female patient). 5. Any clinically significant neurologic disorders (except PNP). 6. Any clinically significant or unstable medical or psychiatric condition that would affect the patient's ability to participate in the study. 7. Patients with severe or unstable cardiovascular, pulmonary, gastrointestinal, hematological, hepatic, renal or endocrine diseases. 8. Severe peripheral vascular disease that may cause intermittent claudication or ischemic ulcers.

Additional Information

Official title Safety and Performance of the BlueWind Medical Reprieve System for the Treatment of Patients With Peripheral Neuropathic Pain (PNP)
Principal investigator Jean Pierre Van Buyten, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Rainbow Medical.