Evaluation of RFID Localization System for Marking and Retrieving Breast Lesions

Health Beacons

Status: Withdrawn

Conditions: Non-palpable Breast Lesions

Treatments: Device: RFID Tag (Health Beacon)

Study type: Observational

Funder types: Industry

Identifiers

NCT01574664

S10-001

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

Subjects scheduled to undergo lumpectomy

Treatment:

Device: RFID Tag (Health Beacon)