NCT05354427已完成不适用
Evaluation of Commercially Available Implantable Spacers, in Prostate Cancer Patients Undergoing Radiotherapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- BioProtect
- 入组人数
- 175
- 试验地点
- 2
- 主要终点
- Evaluation of Rectal radiation Dose
研究概览
简要总结
Assessment of efficacy and safety of implantable spacers when used to reduce the radiation dose delivered to the organs at risk in prostate cancer patients undergoing radiotherapy.
详细描述
Multi-center, retrospective, observational study for assessment of rectal dose reduction following implantation of the BioProtect Balloon Implant System
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •- Males at least 18 years of age, who have undergone radiation therapy with implantable spacers
排除标准
- •Patients whose clinical and pathological data are not available.
- •Patients have been histologically diagnosed with invasive adenocarcinoma that is extracapsular with posterior extension
结局指标
主要结局
Evaluation of Rectal radiation Dose
时间窗: 1 month
Dosimetry change to organs at risk in subjects with prostate cancer who have undergone radiotherapy with implantable spacers when compared to pre-implantation values.
次要结局
- Prostate to rectum spacing(1 month)
研究者
研究点 (2)
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