Assessing the Sensitivity of "SureTouch™" in Identifying Clinically Significant Masses in Women Undergoing Diagnostic and Screening Mammography
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 213
- 试验地点
- 1
- 主要终点
- Primary
研究概览
简要总结
Prospective, case-control study being conducted to determine the sensitivity of the SureTouch device in detecting known masses at a pre-determined level of specificity.
详细描述
This is a single-center, prospective, case-control study being conducted to determine the sensitivity of the SureTouch device in detecting known masses at a pre-determined level of specificity.
Results of the mammography will be compared to the SureTouch examination results.
Subjects will have between 1 and 3 research visits and 3 follow-up surveys, up to two years from the initial visit. The number of visits will be based upon comparison of the SureTouch examination to conventional breast screening techniques (mammogram and ultrasound).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female Subject presenting for screening mammography
- •30-80 years of age, inclusive
- •Able to provide written informed consent
- •Female Subject presenting for diagnostic appointment and/or biopsy
- •30-80 years of age, inclusive
- •1-3 masses per breast
- •Masses between 0.5 cm and 3.5 cm only
排除标准
- •Individuals who are unable to comprehend or unwilling to sign an informed consent form
- •Women younger than 30 or older than 80
- •Pregnant women
- •Women who have undergone bilateral mastectomies
- •Prisoners
- •Masses which are larger than 3.5 cm or smaller than 0.5 cm in size
- •Individuals with more than 3 masses per breast will be excluded due to the complexity of these cases
研究组 & 干预措施
Subjects without messes
Subjects who are believed to be free of masses.
干预措施: SureTouch (Device)
Subjects with known masses
Subjects with known masses.
干预措施: SureTouch (Device)
结局指标
主要结局
Primary
时间窗: 2 years
1. This study examines the sensitivity of the SureTouch™ system, compared with methods that are the current standard of care (screening and diagnostic mammography with ultrasound), to detect clinically significant mass lesions in the breast.
次要结局
- Secondary(2 years)