The MarginProbe System enables real time detection of cancer at or near the surface of excised tissue specimens during surgery for breast cancer.
Patients participating in the trial underwent lumpectomy surgery and were randomized in the operating room to receive either the standard of care (control group), or the standard of care plus MarginProbe (device group).
In the device group, MarginProbe was used to measure each margin of the excised lumpectomy specimen.
If the device registered a positive reading, additional tissue was immediately resected from the adjacent breast cavity surface.
A primary endpoint of the study was complete surgical resection (CSR), which measured the surgeons’ ability to identify and resect all positive margins when present.
Top-line data from the study showed that, when using MarginProbe in addition to standard of care techniques, there was greater than a three-fold increase in surgeons’ ability to identify and immediately resect all positive lumpectomy margins, compared to standard of care techniques alone.
This improvement led to a 57% reduction in patients who were candidates for re-excision (additional surgery) due to positive margins left un-resected on the lumpectomy specimen.
For the device group, the rate of successful CSR was 72%, compared to 22% in the control group (P<0.0001).
Patients who did not achieve successful CSR were considered candidates for re-excision procedures, 42 in the device group compared to 98 in the control group (57 percent reduction, P<0.0001).
Of these candidates, 30 patients in the device group and 62 patients in the control group had a re-excision.
The MarginProbe System is commercially available in Europe.
It is an investigational device in the US.
