BlueWind Reprieve System for the Treatment of PNP

NCT02209896 | Completed

• 1 other identifier: CP-04-001
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

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

Keywords

Peripheral Neuropathic Pain; PNP

Outcome Measures

Primary Outcomes (2)

• The incidence of serious adverse events

  The incidence of serious adverse events (system and/or procedure related events)

  6 months

• Pain assessment

  Pain assessment by Visual Analogue Scale (VAS) as compared to baseline at 6 months post activation

  6 months post system activation

Secondary Outcomes (1)

• Clinical success defined as the effect of the Reprieve System on patient's symptoms

  6 months post system activation

Study Arms (1)

BlueWind Reprieve System

EXPERIMENTAL

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

Device: The Reprieve system

Interventions

The Reprieve system DEVICE

BlueWind Medical neurostimulator for the treatment of neuropathic pain

BlueWind Reprieve System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BlueWind Medical: lead

Study Sites (2)

Rambam Health care campus

Haifa, 3525408, Israel

Location

Edith Wolfson Medical Center

Holon, 58100, Israel

Location

Study Officials

• Ron Dabby, MD

  Wolfson Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2014
• First Posted: August 6, 2014
• Study Start: December 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 11, 2018

Record last verified: 2018-04

Locations

IL (2)