Clinical trial NCT02062398: BlueWind Medical Reprieve System for the Treatment of 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
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Neuropathy
Keywords: PNP
Stimulation
Peripheral neurostimulation
Lead sponsor: BlueWind Medical
Sponsor class: INDUSTRY
First posted: 2014-02-13
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Incidence of System and/or Procedure Related Serious Adverse Events (SAEs).
timeFrame: 6 months
measure: Pain Assessment by Visual Analogue Scale (VAS) as Compared to Baseline at 6 Months Post Activation
timeFrame: 1 Month, 3 Months, and 6 months post system activation
Secondary outcomes:
measure: Clinical Success 6 Months Post Activation
timeFrame: 1 Month, 3 Months, and 6 months post system activation
measure: Clinical Success 6 Months Post Activation
timeFrame: 6 months post activation
measure: Clinical Success 6 Months Post Activation
timeFrame: 1 Month, 3 Months, and 6 months post system activation
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge - Oostende AV
city: Sint-Niklaas
country: Belgium
facility: AZ Sint-Niklaas Hospital
city: Bydgoszcz
country: Poland
facility: 10 Military Clinical Hospital
city: Kraków
country: Poland
facility: CenterMed Kraków Sp.z o.o.
Study officials:
affiliation: Sint-Niklaas hospital
name: Jean Pierre Van Buyten, MD
role: PRINCIPAL_INVESTIGATOR
References: