MarginProbe® System U.S. Post-Approval Study

Status unconfirmed · Not applicable

Conditions studied: Breast Cancer

In brief

The study objective is to determine the MarginProbe® System's diagnostic accuracy at the margin level and impact on Positive Margin\* Presence originating from the Main ex-vivo lumpectomy specimen after the initial lumpectomy surgery. \*A positive margin is defined in this study as a margin microscopically measured and reported in the histology report to have cancer within 1 mm or less of the inked surface

Key facts

Study ID

NCT02406599

Run by

Dune Medical Devices

People needed

440

Starts

2015-06-01

Expected to finish

2021-11-01

Last updated by the study team

2021-08-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women histologically diagnosed with carcinoma of the breast
• Women with non-palpable malignant lesions, requiring image guided localization.
• Undergoing lumpectomy (partial mastectomy) procedure
• Age 18 years or more
• Signed ICF

You may not qualify if…

• Multi-centric disease (histologically diagnosed cancer in two different quadrants of the breast)
• Bilateral disease (diagnosed cancer in both breasts)
• Neo-adjuvant systemic therapy
• Previous radiation in the operated breast
• Prior surgery in the same site in the breast
• Woman histologically diagnosed by an open biopsy procedure
• Implants in the operated breast
• Pregnancy
• Lactation
• Participating in any other investigational study for either drug or device which could influence collection of valid data under this study
• Patients for whom complete cavity shaving is planned (sites where this is the routine practice of the investigator will also be excluded from participation in the study)

Where it is running

• Sibley Memorial Hospital — Washington D.C., District of Columbia, United States
• Baptist MD Anderson Cancer Center — Jacksonville, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• NorthShore University HealthSystem — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• John Hopkins Medicine — Baltimore, Maryland, United States
• Suburban Hospital — Bethesda, Maryland, United States
• Summit Medical Group — Berkeley Heights, New Jersey, United States
• New Mexico University Cancer center — Albuquerque, New Mexico, United States
• Montefiore Medical Center — New York, New York, United States
• PinnacleHealth Cancer Institute — Harrisburg, Pennsylvania, United States

Full record on ClinicalTrials.gov

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