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:
Health Beacons
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
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Purpose
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 | Intervention |
|---|---|
|
Non-palpable Breast Lesions |
Device: RFID Tag (Health Beacon) |
| Study Type: | Observational |
| Study Design: | 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 |
Further study details as provided by Health Beacons:
Primary Outcome Measures:
- 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.
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2012 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Female patients
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01574664
Contacts
| Contact: Eden Guerrero | 858.939.5047 |
Locations
| United States, California | |
| Sharp Memorial Hospital | Not yet recruiting |
| San Diego, California, United States, 92123 | |
| Harbor-UCLA Medical Center | Not yet recruiting |
| Torrance, California, United States, 90502 | |
| Contact: Chrisitne Dauphine, MD 310-222-6715 ChristineDauphine@yahoo.com | |
| Principal Investigator: Christine Dauphine, MD | |
Sponsors and Collaborators
Health Beacons
More Information
No publications provided
| Responsible Party: | Health Beacons |
| ClinicalTrials.gov Identifier: | NCT01574664 History of Changes |
| Other Study ID Numbers: | S10-001 |
| Study First Received: | April 3, 2012 |
| Last Updated: | August 19, 2012 |
| Health Authority: | United States: Food and Drug Administration |
ClinicalTrials.gov processed this record on May 22, 2013