Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part A)
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This multi-center, prospective, open label study analyzed specimens from fifty subjects at two study sites. Patients scheduled to undergo breast-conserving surgery were recruited in accordance with the inclusion and exclusion criteria. The study period per subject was the time it took to assess the ex vivo breast tissue sample using the study device. Image review was conducted after surgery and compared to the margin status findings in the post-operative pathology report.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Women with breast cancer undergoing lumpectomy
Women 18 years of age or older
Signed informed consent form
Women who have been histologically diagnosed with carcinoma of the breast prior to surgery
Patients planning breast preservation and undergoing lumpectomy (partial mastectomy) procedure
Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast)
Neoadjuvant systemic therapy
All T4 tumors
Previous radiation in the operated breast
Prior surgical procedure in the same quadrant
Implants in the operated breast
Participating in any other investigational study for either drug or device which can influence collection of valid data under this study