Post Market Clinical Study to Evaluate the Safety and Performance of the Axxent® Electronic Brachytherapy System in Women With Resected, Early Stage Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Xoft, Inc.
- 入组人数
- 44
- 试验地点
- 10
- 主要终点
- Number of Participants With Delivery of 34 Gy in 10 Fractions
研究概览
简要总结
The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System.
详细描述
The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System for the delivery of radiation therapy as part of breast conserving therapy in women with resected, early stage breast cancer.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age >50 years
- •Tumor with Tis, T1, N0, M0 - (AJC Classification)
- •Invasive ductal carcinoma or ductal carcinoma in situ
- •Negative microscopic surgical margins of at least 1mm in all directions
- •Adequate skin spacing between balloon surface and surface of the skin - (> 7mm)
排除标准
- •Pregnancy or breast-feeding - (During the treatment portion of the study, sexually active women of childbearing age will be asked to use pregnancy prevention)
- •Scleroderma, systemic sclerosis and active lupus
- •Infiltrating lobular histology
研究组 & 干预措施
Treatment
This is a single arm study where all patients are treated with FDA cleared electronic brachytherapy treatment.
干预措施: Electronic brachytherapy (Axxent System) (Radiation)
结局指标
主要结局
Number of Participants With Delivery of 34 Gy in 10 Fractions
时间窗: measured at end of 10th fraction, usually within 7 days
Successful delivery of the radiation treatment defined as a total 34 Gy in a total of 10 fractions, 3.4 Gy per fraction. (Gray = GY is a measure of radiation dose delivered to tissue)
次要结局
- Serious Adverse Device Related Events Reported During the Course of the Study Through 6 Month Follow-up.(Through 6 months)