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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Recruitment Status : Withdrawn (Not required to be registered)
First Posted : April 10, 2012
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
Health Beacons

Study Description
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Brief Summary:
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 or disease Intervention/treatment
Non-palpable Breast Lesions Device: RFID Tag (Health Beacon)

Study Design
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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
Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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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
Study Population
Female patients
Criteria

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
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Information from the National Library of Medicine

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


Locations
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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
Investigators
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Study Director: Murray Reicher, MD Health Beacons
More Information
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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