NCT05354440进行中（未招募）不适用
Long-Term Prospective Post Marketing Clinical Follow Up for Evaluation of the BioProtect Balloon Implant System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- BioProtect
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- Long Term Rectal And Urinary Toxicity and Quality of Life
研究概览
简要总结
Long-Term Prospective Post Marketing Clinical Follow Up for Evaluation of the BioProtect Balloon Implant™ System
详细描述
Multi-center, long-term, prospective, observational study for assessment of late rectal toxicity and quality of life in prostate cancer subjects undergoing radiotherapy by means of IMRT 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
- Prospective
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
- •Subject has previously participated in the BP-007 clinical study and completed their IMRT treatment.
- •Subject agrees to complete all required follow-up visits.
- •Subject provides written Informed Consent prior to any study related procedure
排除标准
- •Subject who completed 48 months of follow-up in the BP-007 study.
- •Subjects who are receiving at the time of the study, any other investigational agents/ devices.
- •Subjects unwilling and/or unable to comply with the provisions of the study protocol.
结局指标
主要结局
Long Term Rectal And Urinary Toxicity and Quality of Life
时间窗: 48 months
Long-term safety as assessed by incidence of urinary and bowel toxicities.
次要结局
未报告次要终点
研究者
研究点 (6)
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