Breast Cancer Clinical Trial
MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery
Summary
The purpose of this study is to show that addition of device use to a routine breast cancer tumor excision procedure is beneficial and assists the surgeon in correctly determining the extent of excision.
Full Description
The study is a prospective, multi-center, randomized, double arm study demonstrating the effectiveness of the device in adjunctive use for locating the tissue for additional excision following primary specimen excision. One arm is a "Standard of Care" (SOC) Control group and the other arm a "Device+SOC" group.In the "Device +SOC" group the surgeon will use the MarginProbe device on the tissue specimen removed during the surgical procedure.The surgeon will use the results derived from the device and other routine assessments to decide if it is necessary to remove some additional breast tissue.
Eligibility Criteria
Inclusion Criteria:
Women histologically diagnosed with carcinoma of the breast
Women with non-palpable malignant lesions, requiring image guided localization.
Undergoing lumpectomy (partial mastectomy) procedure.
Age 18 years or more
Signed ICF
Exclusion Criteria:
Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast)
Bilateral disease (diagnosed cancer in both breasts)
Neoadjuvant systemic therapy
Previous radiation in the operated breast
Prior surgical procedure in the same breast
Implants in the operated breast
Pregnancy
Lactation
Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
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There are 18 Locations for this study
Costa Mesa California, 92627, United States
Los Angeles California, 90033, United States
Los Angeles California, 90048, United States
Newport Beach California, 92658, United States
Orange California, 92868, United States
Orange California, 92868, United States
Washington District of Columbia, 20007, United States
Annapolis Maryland, 21401, United States
Baltimore Maryland, 21202, United States
Baltimore Maryland, 21237, United States
New York New York, 10003, United States
New York New York, 10016, United States
New York New York, 10019, United States
New York New York, 10032, United States
New-York New York, 10021, United States
Allentown Pennsylvania, 18104, United States
Bryn Mawr Pennsylvania, 19010, United States
Arlington Virginia, 22205, United States
Jerusalem , , Israel
Jerusalem , , Israel
Zrifin , 70300, Israel
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