A Prospective Multicenter Study of Transbronchial Microwave Ablation Using Robotic-Assisted Bronchoscopy in Subjects With Oligometastatic Tumors in the Lung
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 18
- 主要终点
- Number of Patients Whose Ablation Resulted in Technique Efficacy
研究概览
简要总结
This is a prospective, multicenter, single-arm study on transbronchial microwave ablation using the NEUWAVE FLEX Microwave Ablation System and Accessories on oligometastatic tumors in the peripheral lung, guided by the Auris MONARCH Platform for visualization and access while using cone beam CT (computed tomography) to confirm probe tip placement and final ablation zone. The primary endpoint is Technique Efficacy, assessed 30-days post-ablation via CT imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Patients Whose Ablation Resulted in Technique Efficacy
时间窗: 30 days post-ablation
Technique Efficacy is defined as ablation of the target tumor(s) with the ablation zone completely overlapping or encompassing the entire target tumor(s) as assessed using CT imaging 30 days (- 7 to +14 days) after the ablation procedure.
次要结局
- Number of Patients Whose Ablation Resulted in Technical Success(Immediately post-ablation (Day 0))
- Number of Patients Who Experienced Local Tumor Progression(Assessed at 3 months, 6 months and 1 year post-ablation)
- Number of Patients Who Experienced Disease Progression(Assessed at 3 months, 6 months and 1 year post-ablation)
- Number of Patients Who Required Repeat Ablation of Target Lesion(Assessed at 3 months, 6 months and 1 year post-ablation)