BlueWind Medical Reprieve System for the Treatment of PNP

Peripheral Neuropathy Clinical Trial

— PNP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02062398
• Other study ID #: CP-02-001
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: December 2015

Study information

• Verified date: November 2018
• Source: Rainbow Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Device:
• The Reprieve System
BlueWind Medical neurostimulator for the treatment of neuropathic pain

Locations

Country	Name	City	State
Belgium	AZ Sint-Jan Brugge - Oostende AV	Brugge
Belgium	AZ Sint-Niklaas Hospital	Sint-Niklaas
Poland	10 Military Clinical Hospital	Bydgoszcz
Poland	CenterMed Kraków Sp.z o.o.	Kraków

Sponsors (1)

Lead Sponsor	Collaborator
BlueWind Medical

Countries where clinical trial is conducted

Belgium,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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