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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Caroline Blane, University of Michigan
ClinicalTrials.gov Identifier:
NCT00724516
First received: July 23, 2008
Last updated: May 18, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention
Mammography
Biopsy, Needle
Device: Novel Breast Compression Paddle

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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.


Enrollment: 10
Study Start Date: June 2007
Study Completion Date: December 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Caroline Blane, M.D. University of Michigan Hospital
  More Information

No publications provided

Responsible Party: Caroline Blane, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00724516     History of Changes
Other Study ID Numbers: HUM00013441
Study First Received: July 23, 2008
Last Updated: May 18, 2012
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 July 29, 2014