NCT02217150已完成不适用
The DFINE STAR™ Tumor Ablation Prospective Clinical Series
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- DFINE Inc.
- 入组人数
- 50
- 试验地点
- 8
- 主要终点
- Change in Pain
研究概览
简要总结
Prospective clinical series to gather post tumor ablation clinical outcomes from subjects with painful spinal metastases 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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The STAR™ Tumor Ablation System is indicated for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.
排除标准
- •The device is contraindicated in subjects with heart pacemakers, or other electronic device implants.
- •The device is contraindicated in vertebral body levels C1-7.
结局指标
主要结局
Change in Pain
时间窗: 1 month
Mean change from baseline in worst pain score per NRPS at one month
次要结局
- Change in Quality of Life(3 months)
- Change if Quality of Life(3 months)
- Change in Function(3 months)
研究者
研究点 (8)
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