DRKS00008916已完成未知
Philips Digital Breast Tomosynthesis trial for CE markets
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 38
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 40 Years 至 one（—）
- 性别
- Female
入选标准
- •Patient is female and 40 years of age or older
- •- Patient will be undergoing a biopsy for a screening-detected abnormality or after presenting with clinical symptoms (e g palpable lump, nipple discharge, nipple retraction, skin irritation or dimpling)
- •- Patient underwent a 2D mammography (FFDM) in this institution with a Philips MicroDose SI L50 or Philips MicroDose L30 system less than 30 days prior to the day of imaging with the investigational device
排除标准
- •- Patient is pregnant or believes she may be pregnant; OR,
- •- Patient is breast feeding; OR
- •- Patient is unable or unwilling to give informed consent, including consent to reuse data for future research; OR
- •- Patient has been part of another clinical trial within last 12 months
研究者
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