A First in Human Feasibility Study to Evaluate the Safety and Effectiveness of the BIOTRONIK Prospera™ SCS System With HomeStream™ Remote Management

  • STATUS
    Not Recruiting
  • End date
    Mar 12, 2024
  • participants needed
    30
  • sponsor
    Biotronik, Inc.
Updated on 10 October 2022

Summary

The BENEFIT-03 Clinical Study is a first in human, prospective, multi-center, single-arm, interventional feasibility study to be conducted in Australia. The purpose of the BENEFIT-03 study is to collect initial safety and effectiveness data on the BIOTRONIK Prospera™ SCS (Spinal Cord Stimulation) System with HomeStream™ Remote Management. Enrolled participants will complete a SCS trial period per the standard of care utilizing the BIOTRONIK Resilience percutaneous SCS trial leads and the BIOTRONIK Prospera™ External Pulse Generator (EPG). Following a successful trial period, participants will be implanted with a permanent BIOTRONIK Prospera™ Implantable Pulse Generator (IPG). Implanted participants will be followed for 24 months post-implant with in-office visits and remote management visits.

Details
Condition Chronic Low-back Pain, Chronic Leg Pain
Treatment Permanent implant of a BIOTRONIK Prospera™ SCS (Spinal Cord Stimulation) System with HomeStream™ Remote Management
Clinical Study IdentifierNCT04683718
SponsorBiotronik, Inc.
Last Modified on10 October 2022

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