Ignite Creation Date:
2024-05-06 @ 2:32 AM
Last Modification Date:
2024-10-26 @ 11:19 AM
Study NCT ID:
NCT02062398
Status:
COMPLETED
Last Update Posted:
2019-12-30
First Post:
2014-02-12
Brief Title:
BlueWind Medical Reprieve System for the Treatment of PNP
Sponsor:
BlueWind Medical
Organization:
BlueWind Medical
Study Overview
Official Title:
Safety and Performance of the BlueWind Medical Reprieve System for the Treatment of Patients With Peripheral Neuropathic Pain PNP
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PNP
Brief Summary:
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
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 eg foot reducing the pain sensation and improving the quality of life for the patient
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 eg foot reducing the pain sensation and improving the quality of life for the patient
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None