A Clinical Analysis of Bella Blankets® Protective Coverlets Used to Increase the Image Quality of Mammograms, Aid as a Quality Standard for EQUIP Clinical Image Quality (CIQ) Compliance Measurements and Improve Patient Satisfaction.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Clinical Image Quality (CIQ) Outcomes of a Participant's Right Breast Mammogram Performed with Bella Blankets Protective Coverlets on the Receptor Plate to a Bare Receptor Plate.
研究概览
简要总结
This study will collect and compare clinical image quality measurements of randomly scheduled, asymptomatic, screening mammography patients, right breast mammogram performed with and without the use of Bella Blankets protective coverlets on the receptor plate.
The measurements will determine if the use of Bella Blankets protective coverlets increases the mammogram's clinical image quality and if Bella Blankets protective coverlets can be used as an aid for EQUIP compliance.
In addition, a patient satisfaction survey will be conducted with participants to determine if the use of Bella Blankets protective coverlets improves patient satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is Female of any race and ethnicity
- •Subject is 40-75 years old
- •Subject is scheduled for a screening mammogram
- •Subject is willing and able to understand and read the Informed consent form
- •Subject has been a patient at Elizabeth Wende Breast Care for 2 years or more
排除标准
- •Subject is Male
- •Subject has been a patient at Elizabeth Wende Breast Care for less than 2 years
- •Subject has had a breast biopsy within the last 2 years
- •Subject has had breast surgery within the last 2 years
- •Subject is scheduled for a Diagnostic mammogram
- •Subject suspects or may be pregnant
- •Subject is currently pregnant or breastfeeding
- •Subject has breast implants
结局指标
主要结局
Clinical Image Quality (CIQ) Outcomes of a Participant's Right Breast Mammogram Performed with Bella Blankets Protective Coverlets on the Receptor Plate to a Bare Receptor Plate.
时间窗: Through the completion of 100 participants; approximately 4 months
Comparison of the Clinical Image Quality (CIQ) analytics, automatically captured by VolparaEnterprise, for the participant's right breast mammogram performed on a receptor plate with Bella Blankets protective coverlets to the same right breast mammogram performed on a bare receptor plate during the same screening mammogram visit.
次要结局
- Patient Satisfaction Survey(Through the completion of 100 participants; approximately 4 months)