NCT02062398

BlueWind Medical Reprieve System for the Treatment of PNP

Safety and Performance of the BlueWind Medical Reprieve System for the Treatment of Patients With Peripheral Neuropathic Pain (PNP)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: BlueWind Medical · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 (e.g. foot), reducing the pain sensation and improving the quality of life for the patient.

Conditions

• Peripheral Neuropathy

Interventions

Type	Name	Description
DEVICE	The Reprieve System	BlueWind Medical neurostimulator for the treatment of neuropathic pain

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2014-02-13
• Last updated: 2019-12-30
• Results posted: 2019-12-30

Locations

4 sites across 2 countries: Belgium, Poland