N/A
N=13
BlueWind Medical Reprieve System for the Treatment of PNP
Peripheral Neuropathy
Bottom Line
View on ClinicalTrials.gov: NCT02062398 ↗Enrolled (actual)
13
Serious AEs
7.7%
Results posted
Dec 2019
Primary outcome: Primary: The Incidence of System and/or Procedure Related Serious Adverse Events (SAEs). — 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- The Reprieve System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- BlueWind Medical
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Incidence of System and/or Procedure Related Serious Adverse Events (SAEs). |
1 | — |
| PRIMARY Pain Assessment by Visual Analogue Scale (VAS) as Compared to Baseline at 6 Months Post Activation |
3.94; 3.75; 3.14; 3.38; 2.79; 2.42 | — |
| SECONDARY Clinical Success 6 Months Post Activation |
65.6; 66.4; 66.9 | — |
| SECONDARY Clinical Success 6 Months Post Activation |
65.6; 66.4; 66.9 | — |
| SECONDARY Clinical Success 6 Months Post Activation |
65.6; 66.4; 66.9 | — |
Summary
The current study will evaluate the safety and performance of the BlueWind Medical Reprieve System for the treatment of Chronic Painful Peripheral Neuropathy.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02062398). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.