MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

The purpose of this study is to show that addition of device use to a routine breast cancer tumor excision procedure is beneficial and assists the surgeon in correctly determining the extent of excision.

Key facts

Study ID

NCT00749931

Run by

Dune Medical Devices

People needed

664

Starts

2008-10-01

Expected to finish

2010-06-01

Last updated by the study team

2014-06-27

Who can join

Age: 18 and older, up to 90. 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…

• Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast)
• Bilateral disease (diagnosed cancer in both breasts)
• Neoadjuvant systemic therapy
• Previous radiation in the operated breast
• Prior surgical procedure in the same breast
• Implants in the operated breast
• Pregnancy
• Lactation
• Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.

Where it is running

• Pacific Breast Care — Costa Mesa, California, United States
• University of Southern California — Los Angeles, California, United States
• Cedars Sinai Hospital — Los Angeles, California, United States
• HOAG Memorial Hospital — Newport Beach, California, United States
• St. Joseph Hospital — Orange, California, United States
• UCIrvine Medical Center — Orange, California, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Anne Arundel Medical Center — Annapolis, Maryland, United States
• Mercy Hospital Services — Baltimore, Maryland, United States
• Franklin Square Hospital Center — Baltimore, Maryland, United States
• Beth Israel Medical Center — New York, New York, United States
• NYU Clinical Cancer Center — New York, New York, United States
• St. Luke's Roosevelt — New York, New York, United States
• Weill Medical College of Cornell University — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Breast Care Center — Allentown, Pennsylvania, United States
• Bryn Mawr Hospital — Bryn Mawr, Pennsylvania, United States
• Virginia Hospital Center — Arlington, Virginia, United States
• Haddasah Medical Organization — Jerusalem, Israel
• Shaare Zedek — Jerusalem, Israel
• Assaf Harofeh Medical Center — Zrifin, Israel

Full record on ClinicalTrials.gov

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