NCT03251937已完成不适用
VERITAS - A Study to Demonstrate the Value of Multiple Modalities Using the Spectra WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 15
- 主要终点
- Percentage of Subjects With 50% or Greater Reduction in Overall Pain From Baseline
研究概览
简要总结
To demonstrate the value of multiple modalities and sustained clinically significant pain relief in patients with chronic pain when using the Boston Scientific Spectra WaveWriter Spinal Cord Stimulator (SCS) System.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic pain of the trunk and/or limbs
- •22 years of age or older at time of enrollment
- •Willing and able to comply with all protocol-required procedures and assessments/evaluations provided in English
- •Willing and capable of giving informed consent
排除标准
- •Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes
- •Significant cognitive impairment that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study
- •Current systemic infection, or local infection in close proximity to the anticipated surgical field
- •Breast-feeding, pregnant or planning to get pregnant during the course of the study or not using adequate contraception
- •Previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
- •Participating, or intends to participate, in another clinical trial that may influence the data that will be collected for this study
研究组 & 干预措施
Spinal Cord Stimulation
Experimental
Spectra WaveWriter SCS System
干预措施: Spectra WaveWriter SCS System (Device)
结局指标
主要结局
Percentage of Subjects With 50% or Greater Reduction in Overall Pain From Baseline
时间窗: 3 months post activation
次要结局
未报告次要终点
研究者
研究点 (15)
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