Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part B)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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This intraoperative study is a prospective study analyzing specimens from fifty subjects. Patients scheduled to undergo breast-conserving surgery will be recruited 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 sample using the study device. Image review will be conducted during 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