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

NCT00724516 | Completed

• 1 other identifier: HUM00013441
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mammography; Biopsy, Needle

Keywords

Mammogram; Biopsy; Needle; Wire; Localization; Compression; Paddle

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Novel Breast Compression Paddle

EXPERIMENTAL

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.

Device: Novel Breast Compression Paddle

Interventions

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.

Novel Breast Compression Paddle

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who are scheduled to undergo a wire localization procedure on the digital mammography unit at the University of Michigan Cancer Center

You may not qualify if:

• Men
• Pregnant Women
• Lactating Women
• Prisoners
• Children under the age of 18
• Mentally impaired individuals

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

• Caroline Blane, M.D.

  University of Michigan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 23, 2008
• First Posted: July 29, 2008
• Study Start: June 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2010
• Last Updated: July 6, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)