Clinical Trial

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

Active, Not Recruiting
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Record status
This record was last updated November 6, 2024 (before its estimated January 2026 completion). Its status may not reflect the trial's current state.
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 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.
Protocol Amendment History 14 amendments
This ClinicalTrials.gov record has been amended 14 times since 2020-12-21; most recent amendment 2024-11-05.
Status change: Recruiting → Active, Not Recruiting 2024-11-05
Status change: Active, Not Recruiting → Recruiting 2023-10-23
Status change: Recruiting → Active, Not Recruiting 2022-09-27
Status change: Not Yet Recruiting → Recruiting 2021-09-24
Trial Details
NCT Number NCT04683718
Lead Sponsor Biotronik, Inc.
Collaborators: Biotronik Australia Pty Ltd., BIOTRONIK Neuro
Conditions Chronic Low-back Pain, Chronic Leg Pain
Enrollment 60 participants
Start Date 2021-09-20
Primary Completion 2026-01 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2024-11-06