Post Market Study of Exablate Model 4000 Type 1.0/1.1 Following the Treatment of Neuropathic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pain Numerical Rating Score (NRS)
研究概览
简要总结
The Exablate 4000 obtained CE Mark for the treatment of Neuropathic Pain in December 2012. The purpose of this post market study is to obtain real world data on the safety and performance of the Exablate treatment for neuropathic pain.
The objective of this study is to capture the change in pain intensity, physical/emotional function, and pain impact for patients diagnosed with neuropathic pain who undergo an Exablate treatment.
详细描述
The purpose of this post market study is to obtain real world data on the safety and performance of the Exablate treatment for neuropathic pain.
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
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women age 30 years or older
- •Subject undergoing an Exablate procedure for their planned neuropathic treatment per local institution standard of care
- •Subject has diagnosis of "definite" neuropathic pain (grading system IASP-NeupSIG)
- •Patient has a score of 6 or higher on the Numeric Rating Scale (NRS)
- •Subject has tried and failed at least three documented medically supervised treatments (including, but not limited to physical therapy, acupuncture, etc.) and has failed medication treatment from at least two different medication classes
- •Subject's pain-related medication regimen is stable 4 weeks prior to the baseline evaluation
- •Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all study visits
排除标准
- •Subject diagnosed with a nociceptive chronic pain syndrome
- •Subject does not agree to participate or is unlikely to participate for the entirety of the study
- •Subject is currently participating in another clinical investigation with an active treatment arm
结局指标
主要结局
Pain Numerical Rating Score (NRS)
时间窗: 12 months
The pain NRS consists of 1 question that will be asked by interviewing the subjects. The subjects will be asked to rate their average pain over the past 24 hours specific to the area(s) of the pain being treated on a 0 (no pain) to 10 (worst imaginable pain) scale. A higher score indicates a higher pain level.
次要结局
未报告次要终点