Evaluating Image Quality and Comfort of an Investigational Curved Paddle Compared to a Standard Paddle
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 443
- 试验地点
- 4
- 主要终点
- Subject Comfort
研究概览
简要总结
The goal of this study is to evaluate patient comfort during compression with a standard flat mammographic paddle and an investigational curved paddle. This is a study that will be performed with x-ray imaging and will be used to determine if an overall reduction in pain can be appreciated in patients without loss in image quality as compared to the current standard mammogram. Another benefit of the curved paddle may be an increase of perceivable and measurable tissue capture.
详细描述
The study will be conducted in the United States at up to 5 centers. The study will enroll up to 600 subjects. The number of subjects was chosen to allow evaluation of screening and diagnostic patients with a variety of breast densities (fatty, scattered densities, heterogeneously dense or extremely dense) and women with a range of breasts sizes that fit on the current detector. The evaluation of pain reduction will be the primary endpoint, while examining the potential of increased tissue capture without a compromise in image quality will be assessed as secondary endpoints. The enrollment will be consecutive for subjects who sign informed consent to participate. Women participating in the study will present for a screening or diagnostic imaging exam.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 —（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
- •Screening Subject is at least 40 years old, Diagnostic subjects are at least 25 years old
- •Subject will be referred for a screening or a diagnostic work-up with tomosynthesis as part of the exam
排除标准
- •Subjects who are pregnant or who think they may be pregnant
- •Subjects lactating or presenting with discharge
- •Women too large for the detector
- •Subjects who cannot give informed consent
结局指标
主要结局
Subject Comfort
时间窗: 1 day (Day of procedure, No follow-up)
The Universal Pain Assessment Tool (UPAT) was used to assess each subject's comfort perception with each paddle (SOC and INV). The UPAT ranges from 0 to 10, where 0 represents 'no pain' and 10 'worst pain possible'.
次要结局
- Breast Tissue Coverage(1 Day (Day of procedure, No Follow-up))
- Overall Determination of Image Quality(1 day (Day of procedure, No Follow-up))