BlueWind Medical Reprieve System for the Treatment of PNP (PNP)

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

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

Study Overview

• Status: Completed
• Conditions: Peripheral Neuropathy
• Intervention / Treatment: Device: The Reprieve System

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brugge, Belgium, 8000
    • Az Sint-Jan Brugge - Oostende Av
  • Sint-Niklaas, Belgium, B-9100
    • AZ Sint-Niklaas Hospital
• Poland
  • Bydgoszcz, Poland, 5 85-981
    • 10 Military Clinical Hospital
  • Kraków, Poland, 31-530
    • Centermed Krakow Sp.z o.o.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The Reprieve system implantation; The Reprieve implant will be implanted for eligible patients. Implant parameter settings will be set according to patient's sensations.	Device: The Reprieve System; BlueWind Medical neurostimulator for the treatment of neuropathic pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Incidence of System and/or Procedure Related Serious Adverse Events (SAEs).	The incidence of system and/or procedure related serious adverse events (SAEs) throughout the entire study period	6 months
Pain Assessment by Visual Analogue Scale (VAS) as Compared to Baseline at 6 Months Post Activation	VAS score assessment at baseline and follow up visits was performed in two ways; Pain Diary VAS score- the analysis was based on the pain diary, processing the average daily VAS scores over seven consecutive days.; Point VAS score- the analysis was based on the VAS score measurement recorded during the baseline visit and following 30 minutes stimulation at all follow up visits.Pain assessment by Visual Analogue Scale (VAS) as compared to baseline, post system activation. Visual Analogue Scale (VAS) for Pain Scores on a scale [0 - 10], higher values represent a worse outcome.	1 Month, 3 Months, and 6 months post system activation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Success 6 Months Post Activation	Clinical success at 6 months post activation was further assessed by:Short-form McGill pain questionnaire. McGill pain questionnaire Scores on a scale Range [0-60] points, higher values represent a worse outcome.	1 Month, 3 Months, and 6 months post system activation
Clinical Success 6 Months Post Activation	Clinical success is defined as the effect of the BlueWind Reprieve System on the treatment of the following symptoms compared to baseline: - Pain related medication consumption/day	6 months post activation
Clinical Success 6 Months Post Activation	Clinical success was further assessed by: Quality of life questionnaire (SF-36 Health Survey) SF-36 Health Survey Scores on a scale [0 - 100], higher values represent a better outcome.	1 Month, 3 Months, and 6 months post system activation

Collaborators and Investigators

• Sponsor: BlueWind Medical
• Investigators: Principal Investigator: Jean Pierre Van Buyten, MD, Sint-Niklaas hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: February 12, 2014
• First Submitted That Met QC Criteria: February 12, 2014
• First Posted (Estimate): February 13, 2014

Study Record Updates

• Last Update Posted (Actual): December 30, 2019
• Last Update Submitted That Met QC Criteria: December 26, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Stimulation; PNP; Peripheral neurostimulation
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: CP-02-001