Radiofrequency (RF) Ablation Prospective Outcomes Study for Central Nervous System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- Change in patient's quality of life (QoL) during the study as compared with baseline
研究概览
简要总结
The objective of this study is to compile real-world outcomes of Boston Scientific commercially approved radiofrequency (RF) ablation systems used in the central nervous system (CNS) for use in functional neurosurgery.
详细描述
The objective of this study is to compile real-world outcomes of Boston Scientific Corporation commercially approved radiofrequency (RF) ablation systems used in the central nervous system (CNS) for use in functional neurosurgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study candidate is scheduled to be treated with a commercially approved Boston Scientific RF system for pain or for CNS applications per local Directions for Use (DFU)
- •Signed a valid, IRB/EC/REB-approved informed consent form
排除标准
- •Meets any contraindications per locally applicable Directions for Use (DFU)
- •Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or to complete study assessments
研究组 & 干预措施
Boston Scientific Radiofrequency Ablation Systems
Subjects treated with Boston Scientific commercially approved radiofrequency (RF) ablation systems in the central nervous system (CNS).
干预措施: Radiofrequency Ablation (Device)
结局指标
主要结局
Change in patient's quality of life (QoL) during the study as compared with baseline
时间窗: Up to 24-Months
Change in quality of life assessments during the study as compared with baseline
次要结局
未报告次要终点