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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2010-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Mammography Biopsy, Needle

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Novel Breast Compression Paddle

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE