Peripheral Neuropathic PainNCT02209896
BlueWind Reprieve System for the Treatment of PNP
A study testing The Reprieve system in people with Peripheral Neuropathic Pain, run by BlueWind Medical at 2 sites in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Neuropathic Pain
- 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
- 2 sitesIsrael
- Study dates
- Dec 2014to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 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
2 sites in 1 country.
Israel2 sites
Rambam Health care campus
Haifa, 3525408
Edith Wolfson Medical Center
Holon, 58100
About this study
Official title: Safety and Performance of the BlueWind Medical Reprieve System for the Treatment of Patients With Peripheral Neuropathic Pain
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 Neuropathic Pain
- Being tested
- The Reprieve system
- Keywords
- Peripheral Neuropathic Pain, PNP
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 group | Role | What they receive |
|---|---|---|
| BlueWind Reprieve System | Experimental | The Reprieve implant will be implanted for eligible patients. Implant parameters 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 serious adverse events
The incidence of serious adverse events (system and/or procedure related events)
Measured: 6 months
Pain assessment
Pain assessment by Visual Analogue Scale (VAS) as compared to baseline at 6 months post activation
Measured: 6 months post system activation
Secondary outcomes (1)
Clinical success defined as the effect of the Reprieve System on patient's symptoms
Measurements include:
SF-McGill pain Questionnaire Pain related medication consumption/day Quality of life questionnaire SF-36 Health survey and safety
Measured: 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.
- First posted6 Aug 2014 (estimated)
- Study startDec 2014
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Neuropathic PainStudies 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)
Sponsor and investigators
- Lead sponsor
- BlueWind Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ron Dabby, MD, Principal investigator, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02209896
- Sponsor's protocol ID
- CP-04-001
- Status last verified
- Apr 2018
- First submitted
- 3 Aug 2014
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. 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
- ClinicalTrials.gov ID
- NCT02209896
- Acronym / sponsor ID
- CP-04-001
- Conditions
- Peripheral Neuropathic Pain
- Keywords
- Peripheral Neuropathic Pain, PNP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- BlueWind MedicalIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 6 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BlueWind Reprieve System | Experimental | Device: The Reprieve systemThe Reprieve implant will be implanted for eligible patients. Implant parameters 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 (7 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).- Any clinically significant or unstable medical or psychiatric condition that would affect the patient's ability to participate in the study.
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 | BlueWind Reprieve System |
Primary outcome
The incidence of serious adverse events
Time frame: 6 months
The incidence of serious adverse events (system and/or procedure related events)
Pain assessment
Time frame: 6 months post system activation
Pain assessment by Visual Analogue Scale (VAS) as compared to baseline at 6 months post activation
1 secondary outcome
Clinical success defined as the effect of the Reprieve System on patient's symptoms
Time frame: 6 months post system activation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
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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.
Ron Dabby, MD principal investigator
Wolfson Medical Center
2 sites in 1 country: 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 Neuropathic Pain, run by BlueWind Medical at 2 sites in Israel.
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 7 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 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 serious adverse events (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?
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 11 Apr 2018.