Chronic Low-back PainNCT04683718
A First in Human Feasibility Study to Evaluate the Safety and Effectiveness of the BIOTRONIK Prospera SCS System with HomeStream Remote Management
A study testing Permanent implant of a BIOTRONIK Prospera SCS (Spinal Cord Stimulation) System with HomeStream Remote Management in people with Chronic Low-back Pain and Chronic Leg Pain, run by Biotronik, Inc. at 5 sites in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Chronic Low-back Pain, Chronic Leg Pain
- What is being tested?
- Permanent implant of a BIOTRONIK Prospera SCS (Spinal Cord Stimulation) System with HomeStream Remote Management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesAustralia
- Study dates
- 20 Sep 2021to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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%
Who cannot join
- 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 investigational device or drug trial for the management of chronic pain
- Patients who have undergone spinal surgery within 12 months prior to enrollment
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- Patients currently involved in an active WorkCover insurance claim and/or active litigation related to injury associated with indication for SCS
- Patients with a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency (other than prescribed) in the 6 months prior to enrollment
- Patients currently displaying opioid-seeking behavior
- Presence of any life-threatening, underlying illness
- Life expectancy less than 1 year
- Patients reporting pregnancy at the time of enrollment or intending to become pregnant during the 2-year study duration
- Patients with opioid dosages > 120 morphine milligram equivalents (MME) per day
- Patients with poor compliance for pain management regimen
- Patients with a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the investigator
- Patients with pain originating from peripheral vascular disease
- Current diagnosis of a coagulation disorder or bleeding diathesis
- Patients with a diagnosis of severe thoracic scoliosis that is likely to preclude SCS lead placement
- Patients who are immunocompromised and/or at high risk for infection
- Patients with a documented history of allergic response or sensitivity to material(s) required for the study (e.g. adhesives, titanium, silicone, etc.)
- At the conclusion of the trial period, the absence of the following exclusion criteria should be confirmed before proceeding with the permanent Prospera SCS System implant:
- Reduction in overall pain of less than 50% from baseline, assessed using VAS
- Unsuccessful trial period as otherwise determined by the investigator
- Determined by the investigator to be a poor candidate for permanent Prospera SCS System implant per standard of care (e.g. due to infection, non-compliance with pain medication regimen, paresis, clumsiness, numbness, and other)
- Additionally, pre-operative screening for staphylococcus aureus (MRSA/MSSA) must be conducted after the SCS trial period and prior to implantation of the permanent device.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Australia5 sites
Genesis Research Services
Broadmeadow, New South Wales, 2292
Monash Clinical Research
Clayton, Victoria, 3168
Australian Medical Research
Hurstville, New South Wales, 2220
Sunshine Coast Clinical Research
Noosa, Queensland, 4567
Sydney Pain Research Centre
Wahroonga, New South Wales, 2076
About this study
Official title: BENEFIT-03 Clinical Study
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.
- Conditions
- Chronic Low-back Pain, Chronic Leg Pain
- Being tested
- Permanent implant of a BIOTRONIK Prospera SCS (Spinal Cord Stimulation) System with HomeStream Remote Management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Permanent implant of a BIOTRONIK Prospera SCS (Spinal Cord Stimulation) System with HomeStream Remote ManagementDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| BIOTRONIK Prosper SCS (Spinal Cord Stimulation) System | Experimental | Eligible participants will be permanently implanted with a BIOTRONIK Prospera SCS (Spinal Cord Stimulation) System with HomeStream Remote Management. Receives: Device: Permanent implant of a BIOTRONIK Prospera SCS (Spinal Cord Stimulation) System with HomeStream Remote Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 6 months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start20 Sep 2021
- Primary completionJan 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotronik, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biotronik Australia Pty Ltd., BIOTRONIK Neuro
- Responsible party
- Sponsor
- Investigators
- Paul Verrills, MD, Study chair, Metro Pain Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683718
- Sponsor's protocol ID
- BENEFIT-03
- Status last verified
- Nov 2024
- First submitted
- 21 Dec 2020
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BENEFIT-03 Clinical Study
- ClinicalTrials.gov ID
- NCT04683718
- Acronym / sponsor ID
- BENEFIT-03
- Conditions
- Chronic Low-back Pain, Chronic Leg Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Biotronik, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Biotronik Australia Pty Ltd., BIOTRONIK Neuro
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIOTRONIK Prosper SCS (Spinal Cord Stimulation) System | Experimental | Device: Permanent implant of a BIOTRONIK Prospera SCS (Spinal Cord Stimulation) System with HomeStream Remote ManagementEligible participants will be permanently implanted with a BIOTRONIK Prospera SCS (Spinal Cord Stimulation) System with HomeStream Remote Management. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (25 listed)
- 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 investigational device or drug trial for the management of chronic pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Permanent implant of a BIOTRONIK Prospera SCS (Spinal Cord Stimulation) System with HomeStream Remote ManagementThe 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. | Device | BIOTRONIK Prosper SCS (Spinal Cord Stimulation) System |
Primary outcome
Overall Responder Rate to the BIOTRONIK Prospera SCS System Therapy
Time frame: 6 months post-implant
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).
Primary Safety Information on the BIOTRONIK Prospera SCS System
Time frame: 6 months post-implant
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Verrills, MD study chair
Metro Pain Group
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Permanent implant of a BIOTRONIK Prospera SCS (Spinal Cord Stimulation) System with HomeStream Remote Management in people with Chronic Low-back Pain and Chronic Leg Pain, run by Biotronik, Inc. at 5 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Responder Rate to the BIOTRONIK Prospera SCS System Therapy (time frame: 6 months post-implant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024; AzTrials last refreshed its copy on 29 Oct 2026.