NCT05914168招募中不适用
Clinical Data Collection in Breast Tomosynthesis: COBRIS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Data Collection
研究概览
简要总结
The purpose of the study is to assess an image acquisition application for breast tomosynthesis in a clinical environment
详细描述
After being informed about the study and potential risks, all patients giving written informed consent will undergo their routine mammography examination. One additional mammography view will be obtained with the investigational application and analyzed. Subject participation is expected to last no more than 30 minutes. After the mammography examination, subjects will be followed according to the hospital standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 35 years or older;
- •Women referred for unilateral or bilateral 2D and 3D mammography;
- •Women able and willing to comply with study procedures;
- •Women able and willing to participate in this study who have signed and dated the informed consent form; and
- •Women surgically sterile or postmenopausal or, the possibility of pregnancy is ruled out based on a negative urine pregnancy test
排除标准
- •Women who have been previously included in this study; or
- •Be a minor, protected adult, adult deprived of liberty by judicial or administrative decision, pregnant, parturient or a breastfeeding mother; or
- •Women with BRCA 1 or BRCA 2 gene mutation
结局指标
主要结局
Data Collection
时间窗: 1 year
Collect clinical breast images obtained with the investigational application.
次要结局
- Assessment of Image Quality(1 year)
研究者
研究点 (1)
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