Biopsy, Needle, Mammography
Conditions
Keywords
Mammogram, Biopsy, Needle, Wire, Localization, Compression, Paddle
Brief summary
The purpose of this study is to evaluate the functionality of a new breast compression paddle used in mammography for wire localization.
Detailed description
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.
Interventions
DEVICENovel Breast Compression Paddle
Instead of using the regular wire localization mammography compression paddle, a new breast compression paddle will be used. The new breast compression paddle is similar to a tennis racquet. It consists of crossing plastic strings that are strung tightly in a frame. The needle/wire can be inserted anywhere between the strings.
Sponsors
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women who are scheduled to undergo a wire localization procedure on the digital mammography unit at the University of Michigan Cancer Center
Exclusion criteria
* Men * Pregnant Women * Lactating Women * Prisoners * Children under the age of 18 * Mentally impaired individuals
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the newly designed breast compression paddle. | 1 year | To objectively determine if the functionality of this new breast compression paddle allows for easier access to the breast during wire localization. |
Countries
United States
Outcome results
None listed