Evaluation Of A Novel Breast Compression Paddle For Wire Localization In Mammography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Evaluate the newly designed breast compression paddle.
研究概览
简要总结
The purpose of this study is to evaluate the functionality of a new breast compression paddle used in mammography for wire localization.
详细描述
Presently, the breast compression paddles that are used in mammography for wire localization are made of plastic and contain a relatively small rectangular shaped opening through which the wire is placed in the breast. When technologists use this paddle, they must carefully position the breast such that the rectangular opening is above the region for wire localization. A novel paddle has been developed which increases the wire localization access area tremendously and should therefore make it easier to perform the procedure. The purpose of this study is to evaluate the functionality of this new compression paddle. The new compression paddle was developed by Biomedical Engineering students in conjunction with Radiologists and a Medical Physicist at the University of Michigan. It was designed and manufactured for a student project in the Mechanical Engineering 450/599 course at the University of Michigan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- 否
入选标准
- •Women who are scheduled to undergo a wire localization procedure on the digital mammography unit at the University of Michigan Cancer Center
排除标准
- •Pregnant Women
- •Lactating Women
- •Prisoners
- •Children under the age of 18
- •Mentally impaired individuals
研究组 & 干预措施
Novel Breast Compression Paddle
Women scheduled to undergo a breast mammography wire localization procedure will have a new breast compression paddle will be used Instead of using the regular wire localization mammography compression paddle.
干预措施: Novel Breast Compression Paddle (Device)
结局指标
主要结局
Evaluate the newly designed breast compression paddle.
时间窗: 1 year
To objectively determine if the functionality of this new breast compression paddle allows for easier access to the breast during wire localization.
次要结局
未报告次要终点
研究者
Caroline Blane
Principal Investigator
University of Michigan