Pilot Study of MammoGRIP for Breast Positioning, Image Quality, and Patient Comfort in Mammography
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Image quality
研究概览
简要总结
To evaluate the effectiveness of MammoGRIP® in improving mammographic image quality and minimizing repeated breast positioning compared to standard practice without MammoGRIP®.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 40-75 years undergoing routine screening or diagnostic mammography
- •Ability to provide informed consent
- •Prior mammogram results are available for the patient in Epic
排除标准
- •History of bilateral mastectomy
- •Active skin condition or open wounds on the breast or chest
- •Known allergy to components of MammoGRIP®
研究组 & 干预措施
MammoGRIP
MammoGRIP® is an FDA-cleared, single-use, topical foam adhesive solution designed to improve technologist grip during breast positioning for mammography. In this study, MammoGRIP® will be used in accordance with the manufacturer's instructions and applied immediately before positioning each breast for imaging.
干预措施: MammoGRIP (Device)
结局指标
主要结局
Image quality
时间窗: Images from the current scan will be compared to the images from a historical scan (1 year prior)
\- Pectoralis muscle visualization in MLO and or CC views
Image Quality
时间窗: Images from the current scan will be compared to the images from a historical scan (1 year prior)
Nipple in profile
次要结局
未报告次要终点