NCT02703818已完成不适用
Multi-Center, Prospective, Clinical Trial of the Senza™ Spinal Cord Stimulation (SCS) System in the Treatment Of Chronic Pain of the Upper Extremities
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Nevro Corp
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Responder Rate
研究概览
简要总结
This is a prospective, multi-center post-market study of the Senza System in subjects with chronic, intractable pain of the upper extremities. Data at follow-up visits will be compared to Baseline data collected at the beginning of the study.
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 —（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 an upper extremity of neuropathic origin, which has been refractory to conservative therapy for a minimum of 3 months.
- •Have an average pain intensity (over a period of 7 days) of an upper extremity of ≥ 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment.
- •Be on stable pain medications for at least 28 days and be willing to stay on those medications with no dose adjustments until activation of the permanently implanted SCS device.
- •Be 18 years of age or older at the time of enrollment.
- •Be an appropriate candidate for the surgical procedures required in this study.
- •Be capable of subjective evaluation, able to read and understand English-written questionnaires, and are able to read, understand and sign the written inform consent in English.
- •Have stable neurological status measured by motor, sensory and reflex function.
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.
- •Have a current diagnosis of a progressive neurological disease.
- •Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure.
- •Have mechanical spine instability as determined.
- •Have significant stenosis, based on MRI.
- •Have an existing drug pump and/or another active implantable device (switched on or off) such as a pacemaker or other SCS devices.
- •Have a condition currently requiring or likely to require the use of whole body MRI or diathermy.
- •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, alcohol or illicit drugs.
- •Be involved in an injury claim under current litigation.
- •Have a pending or approved worker's compensation claim.
- •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.
研究组 & 干预措施
Senza
Experimental
Spinal Cord Stimulation for UEP
干预措施: Senza (Device)
结局指标
主要结局
Responder Rate
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (2)
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