NCT06246526招募中不适用
Real-World Efficacy of Evoke® Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy in Chronic Pain Patients (ULTRA).
Saint Francis Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年1月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- VAS - Visual Analog Scale
研究概览
简要总结
This observational, prospective data collection is designed to evaluate the efficacy of CL-SCS therapy in real-world patients suffering from chronic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Be 18 years of age or older at the time of enrollment.
- •Diagnosed with chronic, intractable pain of the trunk and/or limbs, which has been refractory to conservative therapy for a minimum of 6 months.
- •Subject has a minimum Visual Analog Scale (VAS) score of 60 mm or higher (where 100 mm indicates the worst imaginable pain) at baseline.
- •Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician.
- •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
- •Subject is pregnant or nursing.
- •Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, 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.
- •Be concomitantly participating in another clinical study.
结局指标
主要结局
VAS - Visual Analog Scale
时间窗: Baseline to 12 months
次要结局
- PROMIS-29(Baseline to 12 months)
研究者
研究点 (2)
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