Evaluation of RFID Localization System for Marking and Retrieving Breast Lesions

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2017-06-30

Brief Summary

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The goal of this investigation is to obtain clinical data to show the Health Beacons Radiofrequency Identification (RFID) Localization System is safe and performs as intended as a localization device for marking and retrieving a non-palpable surgical target from the breast.

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Detailed Description

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Conditions

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Non-palpable Breast Lesions

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects scheduled to undergo lumpectomy

RFID Tag (Health Beacon)

Intervention Type DEVICE

The radiologist or surgeon will place the Health Beacons RFID Tag under ultrasonic or stereotactic guidance. The surgeon will use the Tagfinder to locate the lesion.

Interventions

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RFID Tag (Health Beacon)

The radiologist or surgeon will place the Health Beacons RFID Tag under ultrasonic or stereotactic guidance. The surgeon will use the Tagfinder to locate the lesion.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Have had stereotactic or ultrasound-guided biopsy with marker placement
* Have a lesion or biopsy marker that is visible under ultrasound
* Have surgical target \< 6 cm from the skin when lying supine
* Have a discreet surgical target
* Have a lesion in which the center/focal area is defined
* Be at least 18 years of age or older

Exclusion Criteria

* Have a palpable lesion that does not require localization
* Require more than one localization needle for localization of the surgical target
* Have undergone previous open surgical biopsy or lumpectomy in the operative breast
* Have an implant in the operative breast
* Have a cardiac pacemaker or defibrillator device

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No