BlueWind Reprieve System for the Treatment of PNP

BlueWind Medical

Status: Completed

Conditions: Peripheral Neuropathic Pain

Treatments: Device: The Reprieve system

Study type: Interventional

Funder types: Industry

Identifiers

NCT02209896

CP-04-001

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

13 participants in 1 patient group

BlueWind Reprieve System

Experimental group

Description:

The Reprieve implant will be implanted for eligible patients. Implant parameters settings will be set according to patient's sensations.

Treatment:

Device: The Reprieve system