Multi-Center, Prospective, Randomized, Controlled Clinical Trial to Demonstrate Non-Inferiority of the Senza™ Spinal Cord Stimulation (SCS) System in the Treatment of Chronic Pain as Compared to Commercially Available SCS Devices
试验速览
- 阶段
- 不适用
- 发起方
- Nevro Corp
- 入组人数
- 356
- 主要终点
- Change in back pain VAS and neurological status from Baseline
研究概览
简要总结
The purpose of this investigational study is to establish the safety and effectiveness of electrical stimulation delivered to the spinal cord in subjects with chronic, intractable pain of the trunk and/or limbs and will be a comparison of the Senza System with commercially available SCS systems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have been diagnosed with chronic, intractable pain of the trunk and/or limbs (VAS ≥ 5) which has been refractory to conservative therapy for a minimum of 3 months.
- •Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
- •Be 18 years of age or older at the time of enrollment
- •Be willing and capable of giving informed consent
- •Be willing and able to comply with study-related requirements, procedures, and visits
排除标准
- •Have 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
- •Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by a psychologist
- •Have a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus
- •Have a diagnosis of scoliosis that precludes lead placement
- •Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker
- •Have prior experience with SCS
- •Have a condition currently requiring or likely to require the use of MRI or diathermy
- •Have metastatic malignant disease or active local malignant disease
- •Have a life expectancy of less than 1 year
- •Have an active systemic or local infection
- •Be pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal)
- •Have within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs)
- •Be concomitantly participating in another clinical study
- •Be involved in an injury claim under current litigation
- •Have a pending or approved worker's compensation claim
结局指标
主要结局
Change in back pain VAS and neurological status from Baseline
时间窗: 3 months
The primary endpoint is a composite of effectiveness and safety. Specifically, the primary endpoint is the percentage of randomized subjects (the ITT analysis population) and subjects completing the Primary Efficacy Assessment (the PP analysis population) who respond to SCS therapy (as assessed by VAS) for back pain and do not have a stimulation-related neurological deficit at the Primary Efficacy Assessment (non-inferiority analysis). Subjects who do not have a successful Trial Phase are considered failures (non-responders) toward the primary endpoint.
次要结局
- Change in disability as measured by Oswestry Disability Index(3, 6, 12 months)
- Number of subjects with adverse events(12 months)