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.

Study Overview

• Status: Withdrawn
• Conditions: Non-palpable Breast Lesions
• Intervention / Treatment: Device: RFID Tag (Health Beacon)

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Sharp Memorial Hospital
    • Torrance, California, United States, 90502
      • Harbor-UCLA Medical Center
  • Colorado
    • Denver, Colorado, United States, 80218
      • Exempla Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Female patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The surgical target is visualized in the removed specimen AND the RFID Tag was removed from the patient's breast.	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.	Within 96 hours after lumpectomy

Collaborators and Investigators

• Sponsor: Health Beacons
• Investigators: Study Director: Murray Reicher, MD, Health Beacons

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): March 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: April 3, 2012
• First Submitted That Met QC Criteria: April 7, 2012
• First Posted (Estimate): April 10, 2012

Study Record Updates

• Last Update Posted (Actual): May 21, 2020
• Last Update Submitted That Met QC Criteria: May 19, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: S10-001