Evaluation of RFID Localization System for Marking and Retrieving Breast Lesions
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ClinicalTrials.gov Identifier: NCT01574664 |
Recruitment Status :
Withdrawn
(Not required to be registered)
First Posted : April 10, 2012
Last Update Posted : May 21, 2020
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Condition or disease | Intervention/treatment |
---|---|
Non-palpable Breast Lesions | Device: RFID Tag (Health Beacon) |
Study Type : | Observational |
Actual Enrollment : | 0 participants |
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 |
Study Start Date : | September 2012 |
Estimated Primary Completion Date : | March 2017 |
Estimated Study Completion Date : | June 2017 |
Group/Cohort | Intervention/treatment |
---|---|
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. |
- 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.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Study Director: | Murray Reicher, MD | Health Beacons |
Responsible Party: | Health Beacons |
ClinicalTrials.gov Identifier: | NCT01574664 |
Other Study ID Numbers: |
S10-001 |
First Posted: | April 10, 2012 Key Record Dates |
Last Update Posted: | May 21, 2020 |
Last Verified: | May 2020 |