Evaluation of RFID Localization System for Marking and Retrieving Breast Lesions

This study is not yet open for participant recruitment.

Verified August 2012 by Health Beacons

Sponsor:

Information provided by (Responsible Party):

Health Beacons

ClinicalTrials.gov Identifier:

NCT01574664

First received: April 3, 2012

Last updated: August 19, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 3, 2012

Last Updated Date

August 19, 2012

Start Date ^ICMJE

September 2012

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

The surgical target is visualized in the removed specimen AND the RFID Tag was removed from the patient's breast. [ Time Frame: Within 96 hours after lumpectomy ] [ Designated as safety issue: Yes ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01574664 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Evaluation of RFID Localization System for Marking and Retrieving Breast Lesions

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Female patients

Condition ^ICMJE

Non-palpable Breast Lesions

Intervention ^ICMJE

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.

Study Group/Cohort (s)

Subjects scheduled to undergo lumpectomy

Intervention: Device: RFID Tag (Health Beacon)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Eden Guerrero

858.939.5047

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01574664

Other Study ID Numbers ^ICMJE

S10-001

Has Data Monitoring Committee

Responsible Party

Health Beacons

Study Sponsor ^ICMJE

Health Beacons

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Health Beacons

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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