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The current study will evaluate the safety and performance of the BlueWind Medical Reprieve System for the treatment of Chronic Painful Peripheral Neuropathy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Reprieve System | Device | BlueWind Medical neurostimulator for the treatment of neuropathic pain |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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;
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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Pierre Van Buyten, MD | Sint-Niklaas hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Sint-Jan Brugge - Oostende AV | Bruges | 8000 | Belgium | |||
| AZ Sint-Niklaas Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | The Reprieve System Implantation | The Reprieve implant will be implanted for eligible patients. Implant parameter settings will be set according to patient's sensations. The Reprieve System: BlueWind Medical neurostimulator for the treatment of neuropathic pain |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | The Reprieve System Implantation | The Reprieve implant will be implanted for eligible patients. Implant parameter settings will be set according to patient's sensations. The Reprieve System: BlueWind Medical neurostimulator for the treatment of neuropathic pain |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 6 months |
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6 Month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | The Reprieve System Implantation | The Reprieve implant will be implanted for eligible patients. Implant parameter settings will be set according to patient's sensations. The Reprieve System: BlueWind Medical neurostimulator for the treatment of neuropathic pain |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| low grade infection and delayed closure of surgical wound | Infections and infestations | Non-systematic Assessment | The Reprieve implant was explanted approximately after 3 weeks of treatment.Patient was treated with antibiotics. The event terminated without further sequel and was classified as non-procedural related and its relationship to the device was unknown. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amit Korner, VP Clinical Research | BlueWind Medical | +972.74.7218905 | amit.korner@bluewindmedical.com |
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| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| 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 |
| 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 |
| Sint-Niklaas |
| B-9100 |
| Belgium |
| 10 Military Clinical Hospital | Bydgoszcz | 5 85-981 | Poland |
| CenterMed Kraków Sp.z o.o. | Krakow | 31-530 | Poland |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| pain measurement using Visual Analogue Scale | Visual Analogue Scale for Pain 0 (no pain) - 10 (max pain) higher values represent a worse outcome | Mean | Standard Deviation | units on a scale |
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| 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;
Visual Analogue Scale (VAS) for Pain Scores on a scale [0 - 10], higher values represent a worse outcome. | 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. | Posted | Mean | Standard Deviation | score on a scale | 1 Month, 3 Months, and 6 months post system activation |
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| 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. | Only 12 out of 13 patients completed the study. Thus, safety analysis is given for 13 patients and the performance analysis report on 12 patients. | Posted | Mean | Standard Deviation | score on a scale | 1 Month, 3 Months, and 6 months post system activation |
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| 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 | Only 12 out of 13 patients completed the study. Thus, safety analysis is given for 13 patients and the performance analysis report on 12 patients. | Posted | Count of Participants | Participants | 6 months post activation |
|
|
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| 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. | Only 12 out of 13 patients completed the study. Thus, safety analysis is given for 13 patients and the performance analysis report on 12 patients. | Posted | Mean | Standard Error | score on a scale | 1 Month, 3 Months, and 6 months post system activation |
|
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| 0 |
| 13 |
| 1 |
| 13 |
| 4 |
| 13 |
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| implant site discolouration | General disorders | Systematic Assessment |
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| Skin irritatation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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Participating Institution and /or investigator may publish/present the results of the clinical investigation ("publication") only upon prior written consent provided by BlueWind Medical Ltd.
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| Point VAS Score - 1M post system activation |
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| Point VAS score - 3M post system activation |
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| Point VAS Score - 6M post system activation |
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