NCT02948361Enrolling By Invitation不适用
Clinical PRoduct DevelOpment StudyinG the QT Ultrasound® BReast ScannEr With Volunteer SubjectS
QT Ultrasound LLC1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2016年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- QT Ultrasound scans
研究概览
简要总结
Subjects will be scanned on the QT Ultrasound Breast Scanner. For subjects that may have breast calcifications and/or mass(es) and/or other finding(s) on the QT scan image(s), standard imaging modalities (e.g., mammogram and HHUS) will be performed per ACR recommendations.
If available, subjects may provide copies of their breast imaging exams and related reports.
Demographics and medical history will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •At least 18 years old
- •Willing and able to provide written, signed informed consent
- •Willing and able to comply with all study procedures
排除标准
- •Inability to tolerate the scan
- •Present infection risk
- •Allergies to device materials
- •Inability to successfully "fit" breast into the investigational device
- •Currently pregnant as reported by the subject
- •Body weight greater than 400 lbs. (180 kg)
- •Any other conditions that the Investigator determines to interfere with the conduct of the study or evaluation of results
研究组 & 干预措施
QT Ultrasound breast scan
Experimental
干预措施: QT Ultrasound Breast Scan (Other)
结局指标
主要结局
QT Ultrasound scans
时间窗: Scan session is 2 to 3 hours
The capabilities of the QT Ultrasound scanner will be measured by the review of the QT Ultrasound scans at the conclusion of each QT Ultrasound scan session
次要结局
未报告次要终点
研究者
研究点 (1)
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