NCT04673032已完成不适用
Radiofrequency (RF) Ablation Prospective Outcomes Study
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
- 298
- 试验地点
- 27
- 主要终点
- Patient Global Impression of Change (PGIC)
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 in the treatment of patients diagnosed with pain
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 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 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 with pain treated with a commercially approved Boston Scientific RF system
干预措施: Radiofrequency Ablation (Device)
结局指标
主要结局
Patient Global Impression of Change (PGIC)
时间窗: 12-months post-procedure
Using the Patient Global Impression of Change (PGIC) Scale, subjects will rate themselves as: very much improved; much improved; minimally improved; no change; minimally worse; much worse; or very much worse compared with Baseline
次要结局
未报告次要终点
研究者
研究点 (27)
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