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Evaluation Of A Novel Breast Compression Paddle For Wire Localization In Mammography
This study is ongoing, but not recruiting participants.
Sponsored by: University of Michigan
Information provided by: University of Michigan
ClinicalTrials.gov Identifier: NCT00724516
  Purpose

The purpose of this study is to evaluate the functionality of a new compression paddle used in mammography for wire localization.


Condition Intervention
Mammography
Biopsy, Needle
Device: Novel Compression Paddle

MedlinePlus related topics: Mammography
U.S. FDA Resources
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

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Increase the ease of performing the procedure. [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: June 2007
Arms Assigned Interventions
Wire Localization: Experimental
Women who are scheduled to undergo a breast mammography wire localization procedure.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00724516

Locations
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
  More Information

No publications provided

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

Keywords provided by University of Michigan:
Mammogram
Biopsy
Needle
Wire
Localization
Compression
Paddle

ClinicalTrials.gov processed this record on February 12, 2009