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Evaluation of RFID Localization System for Marking and Retrieving Breast Lesions

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by Health Beacons.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01574664
First Posted: April 10, 2012
Last Update Posted: December 11, 2014
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.
Information provided by (Responsible Party):
Health Beacons
April 3, 2012
April 10, 2012
December 11, 2014
September 2012
June 2015   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01574664 on ClinicalTrials.gov Archive Site
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Evaluation of RFID Localization System for Marking and Retrieving Breast Lesions
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
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Female patients
Non-palpable Breast Lesions
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.
Subjects scheduled to undergo lumpectomy
Intervention: Device: RFID Tag (Health Beacon)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
60
August 2015
June 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01574664
S10-001
No
Not Provided
Not Provided
Health Beacons
Health Beacons
Not Provided
Study Director: Murray Reicher, MD Health Beacons
Health Beacons
December 2014