MarginProbe Reduces the Re-excision Rate for Breast Conserving Lumpectomy Surgery
Anna Machleidt: firstname.lastname@example.org
1 Breast Center, Charite ́-Universita ̈tsmedizin Berlin, Charite ́platz 1, 10117 Berlin, Germany
2 Department of Gynecology and Breast Center, Sankt-Gertrauden Hospital, Paretzer Str. 12, 10713 Berlin, Germany
A positive margin status after breast conserving surgery (BCS) is one of the strongest predictors for local recurrence of intraductal (DCIS) and invasive carcinoma. As much as 20–50 % of patients with BCS need to undergo a second operation to receive free margins. In this study we tested the clinical performance of MarginProbe© (Dune Medical Devices, Paoli, PA, USA), a device for the intraoperative evaluation of surgical margins.
A prospective clinical study was performed: The device was utilized in BCS of 150 patients treated at a single facility from November 2012 to June 2013. The re-excision rate was compared to the re-excision rate of a historical group of 172 patients treated with BCS at the same hospital without the application of the device. We analyzed whether the results of MarginProbe© are affected by the morphology, grading, size of the tumor, breast density, age, BMI or the use of marker-wires.
The application of MarginProbe© resulted in an overall decreased re-excision rate of 14.6 %. In the subgroup of DCIS the re-excision rate was reduced from 61.7 to 23.1 %. In the subgroup of invasive lobular carcinomas the re-excision rate decreased from 37.0 to 19.0 %. MarginProbe© results were not affected by grading, tumor size, breast density, age, BMI or marker-wire application.
MarginProbe© detects positive margins in invasive carcinoma, DCIS as well as in invasive lobular carcinoma. The device decreases the re-excision rate after breast conserving surgery significantly. It does not interfere with any of the factors we examined.
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About Dune Medical Devices
Dune Medical Devices was founded in 2002 by Dr. Dan Hashimshony, CEO, to realize the extraordinary medical potential of its proprietary tissue characterization technology. Offering surgeons and radiologists the real-time ability to identify cancerous tissues and react immediately, this technology holds the potential for a broad range of surgical and diagnostic applications. Dune Medical Devices is a privately held company with offices in the U.S. and Israel.
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