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 Prosper 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
The Prospera SCS System is a rechargeable, 16-electrode, MRI conditional Spinal Cord Stimulation system that delivers electrical stimulation to the dorsal column of the spinal cord for the treatment of chronic intractable pain of the trunk and/or limbs.
Genesis Research Services
Broadmeadow, New South Wales, Australia
Australian Medical Research
Hurstville, New South Wales, Australia
Sydney Pain Research Centre
Wahroonga, New South Wales, Australia
Sunshine Coast Clinical Research
Noosa, Queensland, Australia
Monash Clinical Research
Clayton, Victoria, Australia
Overall Responder Rate to the BIOTRONIK Prospera SCS System Therapy
The purpose of primary endpoint 1 is to evaluate the overall responder rate of participants to the BIOTRONIK SCS Therapy at the 6-month follow-up interval. To be classified as a responder, a participant must achieve a reduction in overall pain intensity of at least a 50% from baseline, assessed using the Visual Analog Scale (VAS).
Time frame: 6 months post-implant
Primary Safety Information on the BIOTRONIK Prospera SCS System
The purpose of primary endpoint 2 is to collect primary safety information on the BIOTRONIK Prospera SCS System from permanent implant through the 6-month follow-up interval.
Time frame: 6 months post-implant
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