NCT05199701进行中（未招募）不适用
Prospective Case Collection Study for New Mammography Technologies
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 7,500
- 试验地点
- 29
- 主要终点
- Clinically acceptable image quality of the Investigational Device.
研究概览
简要总结
To evaluate the safety and efficacy of the proposed investigational device and assess its clinical utility in breast cancer screening and diagnosis to support continuing technology development of the investigational technology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subject is female of any race and ethnicity.
- •Subject is at least 35 years old.
- •Subject is indicated for a screening or diagnostic mammogram or breast biopsy.
排除标准
- •Subject is pregnant or thinks she may be pregnant
- •Subject has breast implants, cardiac pacemakers, nipple piercings, or IV ports in the mammography field of view.
- •Subject previously participated in the study.
研究组 & 干预措施
Investigational Mammogram Exam
Experimental
干预措施: Mammography (Device)
结局指标
主要结局
Clinically acceptable image quality of the Investigational Device.
时间窗: 4 years
Questionnaire will be used to measure outcomes
Mammograms can be safety acquired on the Investigational Device.
时间窗: 4 years
Will be determined using the AE assessment.
次要结局
- The ease of positioning and usability of the Investigational Device.(4 years)
- Subject assessment of comfort of the Investigational Device.(4 years)
研究者
研究点 (29)
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