Evaluation of RFID Localization System for Marking and Retrieving Breast Lesions
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01574664|
Recruitment Status : Unknown
Verified December 2014 by Health Beacons.
Recruitment status was: Active, not recruiting
First Posted : April 10, 2012
Last Update Posted : December 11, 2014
|Condition or disease||Intervention/treatment|
|Non-palpable Breast Lesions||Device: RFID Tag (Health Beacon)|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|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 :||June 2015|
|Estimated Study Completion Date :||August 2015|
|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.
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|
|Denver, Colorado, United States, 80218|
|Study Director:||Murray Reicher, MD||Health Beacons|