Previous clinical studies with the MarginProbe (MP) system demonstrated the MP System diagnostic accuracy for identification of cancerous/abnormal tissue at the margins (≤ 1mm) of the ex-vivo lumpectomy specimen. The current study is a prospective data collection study with the enhanced technology, the MP2.0 System and is aimed at collecting data to optimize the system algorithm/procedure and to subsequently validate the system to demonstrate non-inferiority to the MP1.x system. In this study, MP2.0 system will be used on ex-vivo lumpectomy specimens at the Operating Room (OR). The study will collect a library of case information data using the MP2.0 system in sequential cohorts of a minimum of 50 subjects until the software and procedure are optimized. The final analysis sample size will be determined and outlined in the SAP based upon the results of the optimization stage.
Study Type
OBSERVATIONAL
Enrollment
398
The MarginProbe System is an adjunctive diagnostic tool for identification of cancerous tissue at the margins of the ex-vivo lumpectomy specimen following primary excision and is indicated for intraoperative use, in conjunction with standard methods (such as intraoperative imaging and palpation) in patients undergoing breast lumpectomy surgery for previously diagnosed breast cancer.
Glendale Adventist Medical Center
Glendale, California, United States
Mercy Medical Center
Cedar Rapids, Iowa, United States
Logan Health Breast Center
Kalispell, Montana, United States
Englewood Health
Englewood, New Jersey, United States
Health and Hospitals Corporation/Kings County
Brooklyn, New York, United States
Northwell Northern Westchester
Mount Kisco, New York, United States
Northwell Health
Staten Island, New York, United States
Lehigh Valley
Bethlehem, Pennsylvania, United States
Hadassah Medical Organization
Jerusalem, Israel
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: During the lumpectomy surgery
Collect MP2.0 data in cohorts of a minimum of 50 subjects to optimize MP2.0 algorithm and procedure.
The cohorts will continue to be collected until a final algorithm is established and the cohort(s) can be collected with the final algorithm to determine the sensitivity and specificity to demonstrate non-inferiority to the MP1.x system.
Time frame: During the lumpectomy surgery
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