NCT01574664

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2012

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 10, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

May 21, 2020

Status Verified

May 1, 2020

Enrollment Period

4.5 years

First QC Date

April 3, 2012

Last Update Submit

May 19, 2020

Conditions

Non-palpable Breast Lesions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Subjects scheduled to undergo lumpectomy

Device: RFID Tag (Health Beacon)

Interventions

RFID Tag (Health Beacon)DEVICE

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.

Subjects scheduled to undergo lumpectomy

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Female patients

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

Exempla Healthcare

Denver, Colorado, 80218, United States

Location

Study Officials

  • Murray Reicher, MD

    Health Beacons

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2012

First Posted

April 10, 2012

Study Start

September 1, 2012

Primary Completion

March 1, 2017

Study Completion

June 1, 2017

Last Updated

May 21, 2020

Record last verified: 2020-05

Locations

US(3)