NCT02419703终止不适用
The STAR™ Tumor Ablation Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 65
- 试验地点
- 15
- 主要终点
- Pain relief (Numerical Rating Pain Scale), post t-RFA
研究概览
简要总结
Registry collecting data on use of The STAR™ Tumor Ablation System.
详细描述
The STAR Prospective Registry is an observational registry to gather clinical safety and outcome data in patients with painful spinal metastases in the thoracolumbar spine (T1-L5) following targeted radiofrequency ablation (t-RFA) treatment with the STAR™ Tumor Ablation System.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with painful spinal metastatic lesions in thoracolumbar vertebrae (T1-L5) that will be treated with t-RFA using the STAR™ Tumor Ablation System.
- •Have signed informed consent
排除标准
- •Subjects under 18 years old
- •Subjects with heart pacemakers, or other electronic device implants
- •Subjects intended for t-RFA in vertebral body levels C1-7
结局指标
主要结局
Pain relief (Numerical Rating Pain Scale), post t-RFA
时间窗: 1 month
measured by Numerical Rating Pain Scale (NRPS, 0-10 scale)
次要结局
- Pain & Quality of Life Improvement (measured by the FACT G7 & Numerical Rating Pain Scale)(1 week, 1 month, 3 month, 6 month, 12 month)
研究者
研究点 (15)
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