Evaluation Of A Novel Breast Compression Paddle For Wire Localization In Mammography
The purpose of this study is to evaluate the functionality of a new breast compression paddle used in mammography for wire localization.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Evaluation Of A Novel Breast Compression Paddle For Wire Localization In Mammography|
- Evaluate the newly designed breast compression paddle. [ Time Frame: 1 year ] [ Designated as safety issue: No ]To objectively determine if the functionality of this new breast compression paddle allows for easier access to the breast during wire localization.
|Study Start Date:||June 2007|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Experimental: Wire Localization
Women who are scheduled to undergo a breast mammography wire localization procedure.
Device: Novel 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00724516
|United States, Michigan|
|University of Michigan Health System|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Caroline Blane, M.D.||University of Michigan Hospital|