BlueWind Reprieve System for the Treatment of PNP

NCT ID: NCT02209896

Last Updated: 2018-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2017-03-31

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.

Conditions

Peripheral Neuropathic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BlueWind Reprieve System

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

Group Type: EXPERIMENTAL

The Reprieve system

Intervention Type: DEVICE

BlueWind Medical neurostimulator for the treatment of neuropathic pain

Interventions

The Reprieve system

BlueWind Medical neurostimulator for the treatment of neuropathic pain

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BlueWind Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ron Dabby, MD

Role: PRINCIPAL_INVESTIGATOR

Wolfson Medical Center

Locations

Rambam Health care campus

Haifa, , Israel

Edith Wolfson Medical Center

Holon, , Israel

Countries

Israel

Other Identifiers

CP-04-001

Identifier Type: -

Identifier Source: org_study_id