A First in Human Feasibility Study to Evaluate the Safety and Effectiveness of the BIOTRONIK Pros… (NCT04683718) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A First in Human Feasibility Study to Evaluate the Safety and Effectiveness of the BIOTRONIK Prospera SCS System with HomeStream Remote Management
Australia60 participantsStarted 2021-09-20
Plain-language 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.
Who can participate
Age range
18 Years – 79 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Currently indicated for SCS therapy for the treatment of low back and/or leg pain
* Planned permanent implant of BIOTRONIK's Prospera SCS System with HomeStream Remote Management
* Planned placement of two BIOTRONIK Resilience SCS trial leads
* Documented scores of ≥ 60 mm out of 100 mm on the Visual Analog Scale (VAS) for both overall pain intensity and pain intensity in the index area of pain, assessed at the time of enrollment
* Willing and able to comply with all study requirements, including all required procedures, phone and/or video calls, and study visits
* Age greater than or equal to 18 years and less than 80 years
* Able to understand the nature of the study and provide written informed consent
* Able to read, understand, and speak English
* Patient's pain-related medication regimen is stable 4 weeks prior to the baseline evaluation
* Oswestry Disability Index (ODI) score of 41 to 80 out of 100
* Passed psychological evaluation
* For diabetic patients: minimum of one HbA1c test within the last 6 months, with most recent result ≤ 8.0%
Exclusion Criteria:
* Any contraindication for SCS therapy
* Patients with an implanted pacemaker, defibrillator, or any other medical contraindication for SCS therapy
* Currently implanted with an infusion pump or any implantable neurostimulator device
* Previously implanted with a neurostimulation system or prior participation in a trial period for a neurostimulation system
* Currently enrolled in any investi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Responder Rate to the BIOTRONIK Prospera SCS System Therapy
Timeframe: 6 months post-implant
2
Primary Safety Information on the BIOTRONIK Prospera SCS System