Evaluation of RFID Localization System for Marking and Retrieving Breast Lesions

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Health Beacons
Sponsor:
Collaborator:
Pharos Devices
Information provided by (Responsible Party):
Health Beacons
ClinicalTrials.gov Identifier:
NCT01574664
First received: April 3, 2012
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

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 ] [ Designated as safety issue: Yes ]
    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 2014
Estimated Primary Completion Date: June 2014 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
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 ClinicalTrials.gov identifier: NCT01574664

Contacts
Contact: Nancy Confrey 978-287-4635

Locations
United States, California
Sharp Memorial Hospital Not yet recruiting
San Diego, California, United States, 92123
Harbor-UCLA Medical Center Not yet recruiting
Torrance, California, United States, 90502
Contact: Chrisitne Dauphine, MD    310-222-6715    ChristineDauphine@yahoo.com   
Principal Investigator: Christine Dauphine, MD         
United States, Colorado
Exempla Healthcare Recruiting
Denver, Colorado, United States, 80218
Contact: Julie L. Barone, DO    303-837-6529    jbarone1@gmail.com   
Principal Investigator: Jule L. Barone, DO         
Sub-Investigator: Denise Norton, MD         
Sponsors and Collaborators
Health Beacons
Pharos Devices
Investigators
Study Director: Murray Reicher, MD Health Beacons
  More Information

No publications provided

Responsible Party: Health Beacons
ClinicalTrials.gov Identifier: NCT01574664     History of Changes
Other Study ID Numbers: S10-001
Study First Received: April 3, 2012
Last Updated: October 29, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 22, 2014