BENEFIT-03 Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Primary Safety Information on the BIOTRONIK Prospera SCS System
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%
排除标准
- •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.
研究组 & 干预措施
BIOTRONIK Prosper SCS (Spinal Cord Stimulation) System
Eligible participants will be permanently implanted with a BIOTRONIK Prospera SCS (Spinal Cord Stimulation) System with HomeStream Remote Management.
干预措施: Permanent implant of a BIOTRONIK Prospera SCS (Spinal Cord Stimulation) System with HomeStream Remote Management (Device)
结局指标
主要结局
Primary Safety Information on the BIOTRONIK Prospera SCS System
时间窗: 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.
Overall Responder Rate to the BIOTRONIK Prospera SCS System Therapy
时间窗: 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).
次要结局
未报告次要终点