Back to resultsBlueWind Medical Reprieve System for the Treatment of PNP (PNP)
Primary Purpose
Peripheral Neuropathy
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
The Reprieve System
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Neuropathy focused on measuring PNP, Stimulation, Peripheral neurostimulation
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 2-3 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.
Sites / Locations
- AZ Sint-Jan Brugge - Oostende AV
- AZ Sint-Niklaas Hospital
- 10 Military Clinical Hospital
- CenterMed Kraków Sp.z o.o.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
The Reprieve system implantation
Arm Description
The Reprieve implant will be implanted for eligible patients. Implant parameter settings will be set according to patient's sensations.
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
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.
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02062398
Brief Title
BlueWind Medical Reprieve System for the Treatment of PNP
Acronym
PNP
Official Title
Safety and Performance of the BlueWind Medical Reprieve System for the Treatment of Patients With Peripheral Neuropathic Pain (PNP)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BlueWind Medical
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The current study will evaluate the safety and performance of the BlueWind Medical Reprieve System for the treatment of Chronic Painful Peripheral Neuropathy.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy
Keywords
PNP, Stimulation, Peripheral neurostimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The Reprieve system implantation
Arm Type
Experimental
Arm Description
The Reprieve implant will be implanted for eligible patients. Implant parameter settings will be set according to patient's sensations.
Intervention Type
Device
Intervention Name(s)
The Reprieve System
Intervention Description
BlueWind Medical neurostimulator for the treatment of neuropathic pain
Primary Outcome Measure Information:
Title
The Incidence of System and/or Procedure Related Serious Adverse Events (SAEs).
Description
The incidence of system and/or procedure related serious adverse events (SAEs) throughout the entire study period
Time Frame
6 months
Title
Pain Assessment by Visual Analogue Scale (VAS) as Compared to Baseline at 6 Months Post Activation
Description
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.
Time Frame
1 Month, 3 Months, and 6 months post system activation
Secondary Outcome Measure Information:
Title
Clinical Success 6 Months Post Activation
Description
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.
Time Frame
1 Month, 3 Months, and 6 months post system activation
Title
Clinical Success 6 Months Post Activation
Description
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
Time Frame
6 months post activation
Title
Clinical Success 6 Months Post Activation
Description
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.
Time Frame
1 Month, 3 Months, and 6 months post system activation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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 2-3 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Pierre Van Buyten, MD
Organizational Affiliation
Sint-Niklaas hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Sint-Jan Brugge - Oostende AV
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
AZ Sint-Niklaas Hospital
City
Sint-Niklaas
ZIP/Postal Code
B-9100
Country
Belgium
Facility Name
10 Military Clinical Hospital
City
Bydgoszcz
ZIP/Postal Code
5 85-981
Country
Poland
Facility Name
CenterMed Kraków Sp.z o.o.
City
Kraków
ZIP/Postal Code
31-530
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
BlueWind Medical Reprieve System for the Treatment of PNP
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