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.
Brief Title
Evaluation of RFID Localization System for Marking and Retrieving Breast Lesions
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Non-palpable Breast Lesions
Eligibility 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
* 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
Inclusion 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
* 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
Gender
Female
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
50 Years
Minimum Age
18 Years
NCT Id
NCT01574664
Org Class
Industry
Org Full Name
Health Beacons
Org Study Id
S10-001
Overall Status
Withdrawn
Primary Completion Date
Primary Completion Date Type
Estimated
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
Primary Outcomes
Outcome Description
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.
Outcome Measure
The surgical target is visualized in the removed specimen AND the RFID Tag was removed from the patient's breast.
Outcome Time Frame
Within 96 hours after lumpectomy
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Female patients
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
50
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Tova Koenigsberg
Investigator Email
tkoenigs@montefiore.org
Investigator Phone
718-920-7555