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The purpose of this study is to evaluate the functionality of a new breast compression paddle used in mammography for wire localization.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novel Breast Compression Paddle | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel Breast Compression Paddle | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the newly designed breast compression paddle. | To objectively determine if the functionality of this new breast compression paddle allows for easier access to the breast during wire localization. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Caroline Blane, M.D. | University of Michigan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
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