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Clinical Trials/NCT01574664
NCT01574664WithdrawnNot Applicable

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

Health Beacons3 sites in 1 countryStarted: September 2012Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Sponsor
Locations
3
Primary Endpoint
The surgical target is visualized in the removed specimen AND the RFID Tag was removed from the patient's breast.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Health Beacons
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (3)

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