BlueWind Reprieve System for the Treatment of PNP

Peripheral Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02209896
• Other study ID #: CP-04-001
• Status: Completed
• Phase: N/A
• First received: August 3, 2014
• Last updated: April 10, 2018
• Start date: December 2014
• Est. completion date: March 2017

Study information

• Verified date: April 2018
• Source: Rainbow Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Peripheral Neuropathic Pain

Intervention

Device:
• The Reprieve system
BlueWind Medical neurostimulator for the treatment of neuropathic pain

Locations

Country	Name	City	State
Israel	Rambam Health care campus	Haifa
Israel	Edith Wolfson Medical Center	Holon

Sponsors (1)

Lead Sponsor	Collaborator
BlueWind Medical

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of serious adverse events	The incidence of serious adverse events (system and/or procedure related events)	6 months
Primary	Pain assessment	Pain assessment by Visual Analogue Scale (VAS) as compared to baseline at 6 months post activation	6 months post system activation
Secondary	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