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

University of Michigan

Status: Completed

Conditions: Biopsy, Needle; Mammography

Treatments: Device: Novel Breast Compression Paddle

Study type: Interventional

Funder types: Other

Identifiers

NCT00724516

HUM00013441

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Novel Breast Compression Paddle

Experimental group

Description:

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.

Treatment:

Device: Novel Breast Compression Paddle