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Sponsored by: |
University of Michigan |
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Information provided by: | University of Michigan |
ClinicalTrials.gov Identifier: | NCT00724516 |
The purpose of this study is to evaluate the functionality of a new compression paddle used in mammography for wire localization.
Condition | Intervention |
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Mammography Biopsy, Needle |
Device: Novel Compression Paddle |
Study Type: | Interventional |
Study Design: | Supportive Care, Open Label, Single Group Assignment |
Official Title: | Evaluation Of A Novel Breast Compression Paddle For Wire Localization In Mammography |
Enrollment: | 10 |
Study Start Date: | June 2007 |
Arms | Assigned Interventions |
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Wire Localization: Experimental
Women who are scheduled to undergo a breast mammography wire localization procedure.
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Device: Novel Compression Paddle
Instead of using the regular wire localization mammography compression paddle, a new compression paddle will be used. The new 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.
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Presently, the 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | University of Michigan ( Caroline Blane, MD ) |
Study ID Numbers: | HUM00013441 |
Study First Received: | July 23, 2008 |
Last Updated: | July 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00724516 |
Health Authority: | United States: Institutional Review Board |
Mammogram Biopsy Needle Wire |
Localization Compression Paddle |