d older, histologically diagnosed with carcinoma of the breast, with non-palpable malignant lesions requiring image guided localization, and undergoing lumpectomy surgery at one of 21 sites in the U.S. and Israel, were enrolled in the study. Of these women, 596 were randomized in the operating room to one of two evenly distributed groups, either device or control. In the device group, the MarginProbe System was used in addition to standard of care methods to measure each margin of the excised lumpectomy specimen. If the device registered a positive reading, additional tissue was immediately resected from the breast cavity corresponding to the positive margin. All tissue, in both groups, underwent intraoperative specimen imaging before being sent to routine pathology per standard of care.
A primary endpoint of the study was Complete Surgical Resection (CSR), the rate of patients with one or more positive margins (< 1mm) on the lumpectomy specimen, as determined by histology, in whom all positive margins were identified and immediately resected. In the device arm, the rate of CSR was 72 percent (N=117/163) compared to 22 percent (N=33/147) in the control group (P< 0.0001). Total tissue volume excised across all surgeries in both groups was similar, with an average of 93cc removed in the device group compared to 85cc removed in the control group.
No safety concerns were noted in the study. Events were similar across both study groups.
About the MarginProbe™ System
The MarginProbe System enables real time detection of cancer at or near the surface of excised tissue specimens during surgery for breast cancer. This simple and immediate assessment of the surgical margins allows surgeons to immediately excise additional tissue, potentially saving a second procedure.
The MarginProbe System is commercially available in Europe. It is an investigational device in the United States.
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