NCT02081053终止不适用
A Prospective, Multicenter Clinical Study to Evaluate the Clinical Outcomes of Targeted Radiofrequency Ablation and Vertebral Augmentation to Treat Painful Metastatic Vertebral Body Tumor(s)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- DFINE Inc.
- 入组人数
- 30
- 试验地点
- 8
- 主要终点
- Pain relief
研究概览
简要总结
To evaluate the clinical outcomes of minimally invasive targeted radiofrequency tumor ablation (t-RFA) and kyphoplasty (also known as vertebral augmentation) in painful metastatic lesions in the spine.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •One to 2 painful vertebrae (T1-L5) with evidence of osteolytic metastatic lesion with known primary histology with pathologic fracture(s) at index vertebra by MRI
- •Pain score ≥ 4 on the numerical rating pain scale
- •Life expectancy of ≥ 6 months
排除标准
- •Primary tumors of the bone at index vertebra
- •Benign tumors of the bone at index vertebra
- •Osteoblastic tumors at index vertebra
- •Index vertebra with more than one (1) pedicle involved
- •Epidural extension of tumor within 5 mm of the spinal cord or without sufficient room for thermal protective maneuvers
- •Spinal cord compression or canal compromise requiring decompression
- •Radiation therapy is planned to be started on the index vertebra within 4 weeks post procedure
- •Radiation therapy was performed on the index vertebra within 2 months before enrollment
- •Major surgery of the spine was performed within 3 months before enrollment
- •Index vertebra(e) had previous spine surgery including vertebroplasty or kyphoplasty
- •Additional non-kyphoplasty/vertebroplasty surgical treatment is required for the index vertebra
研究组 & 干预措施
RF Ablation and Vertebral Augmentation
Other
干预措施: STAR™ Tumor Ablation System and StabiliT® Vertebral Augmentation System (Device)
结局指标
主要结局
Pain relief
时间窗: 1 month
Measured by the Numerical Rating Pain Scale (NRPS)
次要结局
- Change in pain medications(up to 6 months)
- Change in function(up to 6 months)
- Change in Quality of Life(up to 6 months)
研究者
研究点 (8)
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