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Evaluation of RFID Localization System for Marking and Retrieving Breast Lesions

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by Health Beacons.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Health Beacons Identifier:
First received: April 3, 2012
Last updated: December 10, 2014
Last verified: December 2014
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.

Condition Intervention
Non-palpable Breast Lesions Device: RFID Tag (Health Beacon)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Further study details as provided by Health Beacons:

Primary Outcome Measures:
  • 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 ]
    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.

Estimated Enrollment: 60
Study Start Date: September 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects scheduled to undergo lumpectomy Device: 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.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Female patients

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01574664

United States, California
Sharp Memorial Hospital
San Diego, California, United States, 92123
Harbor-UCLA Medical Center
Torrance, California, United States, 90502
United States, Colorado
Exempla Healthcare
Denver, Colorado, United States, 80218
Sponsors and Collaborators
Health Beacons
Study Director: Murray Reicher, MD Health Beacons
  More Information

Responsible Party: Health Beacons Identifier: NCT01574664     History of Changes
Other Study ID Numbers: S10-001
Study First Received: April 3, 2012
Last Updated: December 10, 2014 processed this record on September 21, 2017