Status:
ACTIVE_NOT_RECRUITING
A First in Human Feasibility Study to Evaluate the Safety and Effectiveness of the BIOTRONIK Prospera SCS System with HomeStream Remote Management
Lead Sponsor:
Biotronik, Inc.
Collaborating Sponsors:
Biotronik Australia Pty Ltd.
BIOTRONIK Neuro
Conditions:
Chronic Low-back Pain
Chronic Leg Pain
Eligibility:
All Genders
18-79 years
Phase:
NA
Brief 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 colle...
Eligibility Criteria
Inclusion
- 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
- 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
- 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.
Key Trial Info
Start Date :
September 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04683718
Start Date
September 20 2021
End Date
January 1 2027
Last Update
November 6 2024
Active Locations (5)
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1
Genesis Research Services
Broadmeadow, New South Wales, Australia, 2292
2
Australian Medical Research
Hurstville, New South Wales, Australia, 2220
3
Sydney Pain Research Centre
Wahroonga, New South Wales, Australia, 2076
4
Sunshine Coast Clinical Research
Noosa, Queensland, Australia, 4567