Evaluation of RFID Localization System for Marking and Retrieving Breast Lesions

Withdrawn

• Conditions: Non-palpable Breast Lesions

• Registration Number: NCT01574664
• Lead Sponsor: Health Beacons

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-03
• Study First Submitted QC: 2012-04-07
• Study First Posted: 2012-04-10
• Study Start: 2012-09
• Primary Completion: 2017-03
• Study Completion: 2017-06
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-19
• Last Update Posted: 2020-05-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The surgical target is visualized in the removed specimen AND the RFID Tag was removed from the patient's breast.	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.

Trial Locations

Locations (3)

Sharp Memorial Hospital; 🇺🇸 San Diego, California, United States

Harbor-UCLA Medical Center; 🇺🇸 Torrance, California, United States

Exempla Healthcare; 🇺🇸 Denver, Colorado, United States