Feasibility Study of the Xoft® Axxent® Electronic Brachytherapy System for the Treatment of Cervical Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Xoft, Inc.
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Safety - Adverse Event Rate and Severity
研究概览
简要总结
The purpose of this study is to evaluate the safety, performance and usability of the Xoft Axxent Electronic Brachytherapy System and Cervical Applicator as incorporated into the physician's current standard treatment practice and in replacement of high-dose-rate after-loaders using Iridium-192 or low-dose-rate Cesium treatments. Data will be collected on treatment delivery, safety, and acute toxicity.
Our hypothesis is that the treatment is safe as incorporated into the physician's current standard of practice.
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
- 性别
- Female
- 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
Safety - Adverse Event Rate and Severity
时间窗: Study Exit (90 days)
Adverse event rate and severity during and following the administration of brachytherapy treatment, through discharge from the treatment facility, and for 3 months after treatment.
次要结局
- Device Performance(Study Exit (90 days))