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

Biotronik

Status

Active, not recruiting

Conditions

Chronic Low-back Pain

Chronic Leg Pain

Treatments

Device: Permanent implant of a BIOTRONIK Prospera SCS (Spinal Cord Stimulation) System with HomeStream Remote Management

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT04683718

BENEFIT-03

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

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 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.