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

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: The study is a prospective, multi-center, randomized, double arm study demonstrating the effectiveness of the device in adjunctive use for locating the tissue for additional excision following primary specimen excision. One arm is a "Standard of Care" (SOC) Control group and the other arm a "Device+SOC" group.In the "Device +SOC" group the surgeon will use the MarginProbe device on the tissue specimen removed during the surgical procedure.The surgeon will use the results derived from the device and other routine assessments to decide if it is necessary to remove some additional breast tissue.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
SOC	Lumpectomy	Standard of Care arm - standard of care lumpectomy procedure
Device + SOC	MarginProbe	Use of the device in addition to the standard of care lumpectomy procedure.
Device + SOC	Lumpectomy	Use of the device in addition to the standard of care lumpectomy procedure.

Primary Outcome Measures

Name	Time	Method
The Primary Effectiveness Endpoint is a Measure of Intraoperative Success in Addressing Positive Margins as Detected by Permanent Pathology)by Additional Oriented Tissue Re-excision From the Surgical Cavity.	two weeks after surgery	Tests the efficacy of the device to intra-operatively assess positive margins (superiority) - CSR is 'positive' when all positive margins, as detected by histology, on the main specimen addressed intra-operatively

Secondary Outcome Measures

Name	Time	Method

Locations (21): NYU Clinical Cancer Center
🇺🇸
New York, New York, United States
Weill Medical College of Cornell University
🇺🇸
New-York, New York, United States
Shaare Zedek
🇮🇱
Jerusalem, Israel
Assaf Harofeh Medical Center
🇮🇱
Zrifin, Israel
Haddasah Medical Organization
🇮🇱
Jerusalem, Israel
Bryn Mawr Hospital
🇺🇸
Bryn Mawr, Pennsylvania, United States
Georgetown University Hospital
🇺🇸
Washington, District of Columbia, United States
Columbia University Medical Center
🇺🇸
New York, New York, United States
HOAG Memorial Hospital
🇺🇸
Newport Beach, California, United States
Beth Israel Medical Center
🇺🇸
New York, New York, United States
St. Luke's Roosevelt
🇺🇸
New York, New York, United States
Virginia Hospital Center
🇺🇸
Arlington, Virginia, United States
St. Joseph Hospital
🇺🇸
Orange, California, United States
Anne Arundel Medical Center
🇺🇸
Annapolis, Maryland, United States
Breast Care Center
🇺🇸
Allentown, Pennsylvania, United States
Mercy Hospital Services
🇺🇸
Baltimore, Maryland, United States
University of Southern California
🇺🇸
Los Angeles, California, United States
Pacific Breast Care
🇺🇸
Costa Mesa, California, United States
Cedars Sinai Hospital
🇺🇸
Los Angeles, California, United States
UCIrvine Medical Center
🇺🇸
Orange, California, United States
Franklin Square Hospital Center
🇺🇸
Baltimore, Maryland, United States