Computed Optical Margin Assessment for Breast Cancer Surgery
This study is a multi-center, prospective, open label study of approximately fifty (50) subjects at two (2) study sites, Johns Hopkins Hospital and Anne Arundel Medical Center. Patients scheduled to undergo lumpectomy will be recruited by the clinical investigators at the investigational site in accordance with the inclusion and exclusion criteria. The study period per subject is the time it takes to assess the ex vivo breast tissue samples using the study device during their lumpectomy. This trial compares intraoperative imaging analysis of breast tumor margins to results from post-operative histology. The study will evaluate the ability to identify margin ...
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