Record Status This is a bibliographic record of a published health technology assessment. No evaluation of the quality of this assessment has been made for the HTA database. Citation HAYES, Inc.. MarginProbe System (Dune Medical Devices) for intraoperative assessment of surgical margins in patients with breast cancer. Lansdale: HAYES, Inc.. Healthcare Technology Brief Publication. 2016 Authors' conclusions Description of Technology: MarginProbe uses principles of radiofrequency (RF) spectroscopy to determine whether breast-conserving surgery margins are clear or not based on specific differences in dielectric properties of malignant and benign cells. The MarginProbe System includes a freestanding portable console unit with a user interface and a disposable, sterile probe. In using MarginProbe, a surgeon takes 5 to 12 measurements on each of 6 margin surfaces of a lumpectomy specimen by touching the disposable probe to the specimen surface. Via the probe, the device delivers a wide range of RF signals to excised tissue and analyzes levels of reflection and absorption of RF energy within the specimen. Each measurement takes approximately 1 second. A classification algorithm compares the specimen with known tissues in a database of cancerous and noncancerous breast tissues, generating visible and audible output that categorizes
the specimen surface as positive or negative for the presence of cancer cells.
Patient Population: MarginProbe is indicated for intraoperative use, in conjunction with standard of care methods (such as intraoperative imaging and palpation), to assess excised tumor margins for the presence of
malignant cells in patients who undergo lumpectomy for previously diagnosed breast cancer. Indexing Status Subject indexing assigned by CRD MeSH Breast Neoplasms; Humans; Mastectomy, Segmental Language Published English Country of organisation United States English summary An English language summary is available. Address for correspondence HAYES, Inc., 157 S. Broad Street, Suite 200, Lansdale, PA 19446, USA. Tel: 215 855 0615; Fax: 215 855 5218 Email: hayesinfo@hayesinc.com AccessionNumber 32016000959 Date abstract record published 30/08/2016 |