This trial is active, not recruiting.

Condition non-palpable breast lesions
Treatment rfid tag (health beacon)
Sponsor Health Beacons
Start date September 2012
End date June 2015
Trial size 60 participants
Trial identifier NCT01574664, S10-001


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
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.

Primary Outcomes

The surgical target is visualized in the removed specimen AND the RFID Tag was removed from the patient's breast.
time frame: Within 96 hours after lumpectomy

Eligibility Criteria

Female participants from 18 years up to 50 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Health Beacons.