Peripheral NeuropathyPNPNCT02062398

BlueWind Medical Reprieve System for the Treatment of PNP

A study testing The Reprieve System in people with Peripheral Neuropathy, run by BlueWind Medical at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Peripheral Neuropathy
What is being tested?: The Reprieve System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 4 sitesin 2 countries
Study dates: May 2014to Dec 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

4 sites in 2 countries.

Country

City, postcode or hospital

4 sites in 2 countries

Belgium2 sites

AZ Sint-Jan Brugge - Oostende AV
Bruges, 8000
AZ Sint-Niklaas Hospital
Sint-Niklaas, B-9100

Other trials in Belgium

Poland2 sites

10 Military Clinical Hospital
Bydgoszcz, 5 85-981
CenterMed Kraków Sp.z o.o.
Krakow, 31-530

Other trials in Poland

About this study

Official title: 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.

Read the 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.

Conditions: Peripheral Neuropathy
Being tested: The Reprieve System
Keywords: PNP, Stimulation, Peripheral neurostimulation
Medical subject headings: Peripheral Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

The Reprieve SystemDevice
BlueWind Medical neurostimulator for the treatment of neuropathic pain

Study groups in NCT02062398
Study group	Role	What they receive
The Reprieve system implantation	Experimental	The Reprieve implant will be implanted for eligible patients. Implant parameter settings will be set according to patient's sensations. Receives: Device: The Reprieve System

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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;
1. Pain Diary VAS score- the analysis was based on the pain diary, processing the average daily VAS scores over seven consecutive days.
2. 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.
Measured: 1 Month, 3 Months, and 6 months post system activation

Secondary outcomes (3)

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.
Measured: 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
Measured: 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.
Measured: 1 Month, 3 Months, and 6 months post system activation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2014Dec 2015

First posted13 Feb 2014 (estimated)
Study startMay 2014
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02062398
Sponsor's protocol ID: CP-02-001
Acronym: PNP
Status last verified: Nov 2018
First submitted: 12 Feb 2014
Last updated: 30 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis

All Peripheral Neuropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Performance of the BlueWind Medical Reprieve System for the Treatment of Patients With Peripheral Neuropathic Pain (PNP)
ClinicalTrials.gov ID: NCT02062398
Acronym / sponsor ID: PNP / CP-02-001
Conditions: Peripheral Neuropathy
Keywords: PNP, Stimulation, Peripheral neurostimulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: BlueWind MedicalIndustry (pharma, biotech, devices)
Study start: May 2014 (actual)
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 13 Feb 2014 (estimated)
Results: Posted 30 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
The Reprieve system implantation	Experimental	Device: The Reprieve SystemThe Reprieve implant will be implanted for eligible patients. Implant parameter settings will be set according to patient's sensations.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (8 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
The Reprieve SystemBlueWind Medical neurostimulator for the treatment of neuropathic pain	Device	The Reprieve system implantation

Primary outcome

The Incidence of System and/or Procedure Related Serious Adverse Events (SAEs).
Time frame: 6 months
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
Time frame: 1 Month, 3 Months, and 6 months post system activation
VAS score assessment at baseline and follow up visits was performed in two ways; 1. Pain Diary VAS score- the analysis was based on the pain diary, processing the average daily VAS scores over seven consecutive days. 2. 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.

3 secondary outcomes

Clinical Success 6 Months Post Activation
Time frame: 1 Month, 3 Months, and 6 months post system activation
Clinical Success 6 Months Post Activation
Time frame: 6 months post activation
Clinical Success 6 Months Post Activation
Time frame: 1 Month, 3 Months, and 6 months post system activation

Results and safety

Results posted to the registry on 30 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
The Reprieve System Implantation	13	12

Primary outcome: The Incidence of System and/or Procedure Related Serious Adverse Events (SAEs).

Time frame: 6 months. Count of participants. Unit: Participants

Measure	The Reprieve System Implantation n = 13
Value	1

Primary outcome: Pain Assessment by Visual Analogue Scale (VAS) as Compared to Baseline at 6 Months Post Activation

Time frame: 1 Month, 3 Months, and 6 months post system activation. Mean (Standard Deviation). Unit: score on a scale

Measure	The Reprieve System Implantation n = 12
Pain Diary VAS Score - 1M post system activation	3.94 (1.67)
Pain Diary VAS score - 3M post system activation	3.75 (1.67)
Pain Diary VAS Score - 6M post system activation	3.14 (1.52)
Point VAS Score - 1M post system activation	3.38 (2.48)
Point VAS score - 3M post system activation	2.79 (2.40)
Point VAS Score - 6M post system activation	2.42 (2.61)

Population analysed: Out of the 13 treated patients, one device was explanted approximately after 3 weeks of treatment. Thus, safety analysis is given for 13 patients and the performance analysis report on 12 patients.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 Month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
The Reprieve System Implantation	1 of 13 (7.7%)	4 of 13 (30.8%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Peripheral Neuropathy

Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jean Pierre Van Buyten, MD principal investigator

Sint-Niklaas hospital

4 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing The Reprieve System in people with Peripheral Neuropathy, run by BlueWind Medical at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Belgium, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Incidence of System and/or Procedure Related Serious Adverse Events (SAEs). (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02062398.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2019.