Evaluation Of A Novel Breast Compression Paddle For Wire Localization In Mammography

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation Of A Novel Breast Compression Paddle For Wire Localization In Mammography

Conditions
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Mammography, Biopsy, Needle

Intervention / Treatment
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* Device: Novel Breast Compression Paddle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Novel Breast Compression Paddle<br>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. | Device: Novel Breast Compression Paddle<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mammogram, Biopsy, Needle, Wire, Localization, Compression, Paddle