Evaluation of RFID Localization System for Marking and Retrieving Breast Lesions

A Prospective, Single-Arm, Multicenter Clinical Study to Evaluate the Safety and Performance of the Health Beacons Radiofrequency Identification (RFID) Localization System for Marking and Retrieving Non-Palpable Breast Lesions

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01574664

Enrollment

Registered

2012-04-10

Start date

2012-09-30

Completion date

2017-06-30

Last updated

2020-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-palpable Breast Lesions

Brief summary

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.

Interventions

DEVICERFID 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The surgical target is visualized in the removed specimen AND the RFID Tag was removed from the patient's breast.	Within 96 hours after lumpectomy	The study endpoints are known soon after the lumpectomy procedure by 1) confirmation of the pathology lab examination; and 2) retrieval of the implanted RFID tag.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026