Evaluation of RFID Localization System for Marking and Retrieving Breast Lesions

Sponsor

Health Beacons (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01574664

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-palpable Breast Lesions	Device: RFID Tag (Health Beacon)

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Study Start Date :

Sep 1, 2012

Anticipated Primary Completion Date :

Mar 1, 2017

Anticipated Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sharp Memorial Hospital	San Diego	California	United States	92123
2	Harbor-UCLA Medical Center	Torrance	California	United States	90502
3	Exempla Healthcare	Denver	Colorado	United States	80218

Sponsors and Collaborators

Health Beacons

Investigators

Study Director: Murray Reicher, MD, Health Beacons

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Health Beacons

ClinicalTrials.gov Identifier:

NCT01574664

Other Study ID Numbers:

S10-001

First Posted:

Apr 10, 2012

Last Update Posted:

May 21, 2020

Last Verified:

May 1, 2020

Study Results

No Results Posted as of May 21, 2020