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

Mammography Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00724516
• Other study ID #: HUM00013441
• Status: Completed
• Phase: N/A
• First received: July 23, 2008
• Last updated: July 3, 2017
• Start date: June 2007
• Est. completion date: December 2010

Study information

• Verified date: July 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biopsy, Needle
• Mammography

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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