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.

Completed

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Key information

Conditions

Mammography Biopsy, Needle

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Novel Breast Compression Paddle

Device

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.

Primary outcomes

Evaluate the newly designed breast compression paddle.

Time frame: 1 year

To objectively determine if the functionality of this new breast compression paddle allows for easier access to the breast during wire localization.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2010
First posted: Jul 29, 2008
Registry last updated: Jul 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed