NCT00747253已完成1 期
AutoLITT™ FIM Trial - A Prospective First-In-Man (FIM) Safety Trial of the AutoLITT Laser Treatment of Recurrent/Progressive Brain Tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Primary endpoint is safety, as determined by absence of severe clinical toxicity or procedure-related neurological deficits
研究概览
简要总结
The main purpose of this study is to evaluate the safety and performance of the AutoLITT system for the treatment of recurrent/progressive glioblastoma multiforme tumors (GBM).
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
- •Previous diagnosis of GBM treated with radiotherapy with or without surgical resection and/or chemotherapy
- •Clinical/radiographic suspicion of tumor recurrence/progression
排除标准
- •Previous treatment of target GBM with stereotactic radiosurgery, brachytherapy, or carmustine impregnated wafers (Gliadel).
结局指标
主要结局
Primary endpoint is safety, as determined by absence of severe clinical toxicity or procedure-related neurological deficits
时间窗: 14 days post-surgery
次要结局
未报告次要终点
研究者
研究点 (4)
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