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

Not Applicable

Completed

• Conditions: Mammography; Biopsy, Needle
• Interventions: Device: Novel Breast Compression Paddle

• Registration Number: NCT00724516
• Lead Sponsor: University of Michigan

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2008-07-23
• Study First Submitted QC: 2008-07-24
• Study First Posted: 2008-07-29
• Primary Completion: 2009-12
• Study Completion: 2010-12
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-03
• Last Update Posted: 2017-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Novel Breast Compression Paddle	Novel Breast Compression Paddle	Women scheduled to undergo a breast mammography wire localization procedure will have a new breast compression paddle will be used Instead of using the regular wire localization mammography compression paddle.

Primary Outcome Measures

Name	Time	Method
Evaluate the newly designed breast compression paddle.	1 year	To objectively determine if the functionality of this new breast compression paddle allows for easier access to the breast during wire localization.

Trial Locations

Locations (1)

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States