Expired Study
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Baltimore, Maryland 21231


Purpose:

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.


Criteria:

Inclusion Criteria: 1. Women 18 years of age or older 2. Signed informed consent form 3. Women who have been histologically diagnosed with carcinoma of the breast prior to surgery 4. Patients planning breast preservation and undergoing lumpectomy (partial mastectomy) procedure Exclusion Criteria: 1. Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast) 2. Neoadjuvant systemic therapy 3. All T4 tumors 4. Previous radiation in the operated breast 5. Prior surgical procedure in the same quadrant 6. Implants in the operated breast 7. Pregnancy 8. Lactation 9. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study


NCT ID:

NCT02313116


Primary Contact:

Principal Investigator
Lisa Jacobs
Johns Hopkins Medicine


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21231
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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