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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

April 3, 2012
October 29, 2013
September 2012
June 2014   (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 ] [ 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.
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
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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.
 
Recruiting
60
August 2014
June 2014   (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
Female
18 Years to 50 Years
No
Contact: Nancy Confrey 978-287-4635
United States
 
NCT01574664
S10-001
No
Health Beacons
Health Beacons
Pharos Devices
Study Director: Murray Reicher, MD Health Beacons
Health Beacons
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP