Evaluation of RFID Localization System for Marking and Retrieving Breast Lesions

Non-palpable Breast Lesions Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01574664
• Other study ID #: S10-001
• Status: Withdrawn
• Start date: September 2012
• Est. completion date: June 2017

Study information

• Verified date: May 2020
• Source: Health Beacons
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Non-palpable Breast Lesions

Intervention

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.

Locations

Country	Name	City	State
United States	Exempla Healthcare	Denver	Colorado
United States	Sharp Memorial Hospital	San Diego	California
United States	Harbor-UCLA Medical Center	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Health Beacons

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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