NCT02924129已完成不适用
A Prospective, Multicenter, Randomized Double-blind Study Examining the Safety and Efficacy of Using the Evoke™ Spinal Cord Stimulator (SCS) System With Feedback to Treat Patients With Chronic Pain of the Trunk and/or Limbs.
Saluda Medical Americas, Inc.31 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2017年1月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 31
- 主要终点
- Number of Participants With Composite Endpoint Success
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of the Saluda Medical Evoke SCS System with feedback control to treat chronic pain of the trunk and/or limbs.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is male or female between the ages of 18 and 80 years.
- •Have been diagnosed with chronic, intractable pain of the trunk and/or limbs, which has been refractory to conservative therapy for a minimum of 6 months.
- •Be an appropriate candidate for an SCS trial and the surgical procedures required in this study based on the clinical judgment of the Investigator.
- •Be willing and capable of giving informed consent 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 outcomes.
- •Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS).
- •Have prior experience with SCS.
- •Have an active systemic infection or local infection in the area of the surgical site.
- •Be pregnant or nursing (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).
- •Be concomitantly participating in another clinical study.
结局指标
主要结局
Number of Participants With Composite Endpoint Success
时间窗: 3 months
The primary endpoint is a composite endpoint. A success is defined as a reduction in overall trunk and limb VAS pain score greater than or equal to 50 percent and no increase in baseline pain medication. VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.
次要结局
- Percent Change From Baseline in Back Pain VAS Score(12 months)
- Percent Change From Baseline in Leg Pain VAS Score(12 months)
- Number of Participants With Composite Endpoint Success(12 months)
- Proportion of Subjects With Greater Than or Equal to 80% Reduction From Baseline in Overall Trunk and Limb Pain VAS Score(12 months)
- Proportion of Subjects With Greater Than or Equal to 50% Reduction From Baseline in Back Pain VAS Score(12 months)
研究者
研究点 (31)
Loading locations...
相似试验
招募中
不适用
Real-World Efficacy of Evoke® Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy in Chronic Pain Patients (ULTRA).PainChronic PainNeuropathic PainNCT06246526Saint Francis Hospital50
已完成
不适用
SCS as an Option for Chronic Low Back and/or Leg Pain Instead of SurgeryChronic PainNCT04676022Boston Scientific Corporation241
已完成
不适用
Shockwave Coronary Rx Lithoplasty® Study (Disrupt CAD I)Coronary Artery DiseaseNCT02650128Shockwave Medical, Inc.60
Unknown
不适用
Efficacy and Safety of Spinal Cord Stimulation in Patients With Chronic Intractable PainPainChronic PainBack PainSpinal Cord StimulationNervous System DiseasesNCT03858790Beijing Pins Medical Co., Ltd54
已完成
不适用
Wireless Spinal Cord Stimulation for Chronic PainBack PainNCT02514590Curonix LLC49