NCT02389855已完成不适用
Laser Ablation in Stereotactic Neurosurgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 9
- 主要终点
- Endpoint 1: Procedural Success Endpoint 2: Progression-Free Survival Endpoint 3: Overall Survival Endpoint 4: Karnofsky performance status
研究概览
简要总结
The NeuroBlate® System (NBS), is a minimally invasive robotic laser thermotherapy tool. It employs a pulsed surgical laser to deliver targeted energy to abnormal brain tissue caused by tumors and lesions. Since receiving FDA clearance in April 2013, the NBS has been used in nearly 300 procedures conducted at approximately 20 leading institutions across the United States. This post-market, multi-center retrospective study is designed to collect long-term follow-up data on patients who were treated previously with NBS.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient was previously treated with NBS
- •Patient is willing and able to provide informed consent and authorization for release of personal health information or IRB waiver is granted to collect study information without patient consent
排除标准
- •There are no exclusion criteria for this study.
结局指标
主要结局
Endpoint 1: Procedural Success Endpoint 2: Progression-Free Survival Endpoint 3: Overall Survival Endpoint 4: Karnofsky performance status
时间窗: up to 24 months
Retrospective data collection.
次要结局
- Adverse Events(up to 24 months)
研究者
研究点 (9)
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