Evaluation of RFID Localization System for Marking and Retrieving Breast Lesions
This trial is active, not recruiting.
|Condition||non-palpable breast lesions|
|Treatment||rfid tag (health beacon)|
|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|
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
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
|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|
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