A Real Word Study to Evaluate the Safety and Performance of SpaceOAR System When Used to Create Space Between the Rectum and Prostate in Men Undergoing Radiotherapy for Localized T1-T2 Prostate Cancer in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Primary Effectiveness Endpoint
研究概览
简要总结
This study aims to evaluate the safety and performance of SpaceOAR System when it is used to create space between the rectum and prostate in men undergoing radiotherapy for localized T1-T2 prostate cancer in China via collecting the real word data of SpaceOAR System used, to generate local clinical evidence on Chinese patients.
详细描述
This study is a retrospective and prospective, single arm, real world study. For those patients who have already received the SpaceOAR treatment before study kick-off, the data at baseline and the day of procedure will be retrospectively collected. For those patients who will receive SpaceOAR treatment after study kick-off, the clinical data at baseline, the day of procedure and 30 days post procedure will be prospectively collected.
Up to 20 subjects with a pathologically confirmed diagnosis of clinical stage T1 or T2 prostate cancer indicated for radiotherapy will be enrolled, for there are chances of missing data in the real world study. A sample of 14 subjects provides at least 90% power for the primary objective.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects has provided the written informed consent, willing to participate in clinical data collection and willing to receive visit at 30 days post procedure. (for subjects enrolled prospectively)
- •Subjects must have been pathologically confirmed prostate cancer with clinical stage T1-T2, and have been treated or will be treated with Space OAR Hydrogel in hospital in Hainan Boao Lecheng medical pilot zone.
- •Exclusion Criteria- no specific exclusion criteria unless the patients refuse to sign the informed consent.
排除标准
- 未提供
结局指标
主要结局
Primary Effectiveness Endpoint
时间窗: Within 10 days post spaceOAR hydrogel administration.
The distance between the posterior prostatic capsule and anterior rectal wall,
Primary Safety Endpoint
时间窗: Within 30 days following procedure
Subjects with AEs related to SpaceOAR system and/or procedure within 30 days following procedure will be observed.
次要结局
- Functional Success(Within 10 days post spaceOAR hydrogel administration.)