MarginProbe 2.0 Data Collection Protocol

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

MarginProbe2.0

Clinical Study ID

NCT05377229

CP-13-001

Ages > 18
Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Women over 18 years of age
Diagnosed with cancer, undergoing lumpectomy or partial mastectomy procedure
Signed Informed Consent Form

Exclusion

Exclusion Criteria:

Undergoing re-excision procedure
Concurrent infectious disease
Pregnancy
Lactation
Previous surgery in the same site including open biopsy procedure, previous breastreduction or mastopexy in the operated breast
Prior radiation treatment in the operated breast
Participating in any other investigational study for either drug or device which caninfluence collection of valid data under this study

Study Design

MarginProbe2.0

December 15, 2021

January 12, 2025

Connect with a study center

Hadassah Medical Organization
Jerusalem, 91120
Israel
Site Not Available
Hadassah Medical Organization
Jerusalem 281184, 91120
Israel
Site Not Available
Glendale Adventist Medical Center
Glendale, California 91206
United States
Site Not Available
Glendale Adventist Medical Center
Glendale 5352423, California 5332921 91206
United States
Site Not Available
Mercy Medical Center
Cedar Rapids, Iowa 52403
United States
Site Not Available
Mercy Medical Center
Cedar Rapids 4850751, Iowa 4862182 52403
United States
Site Not Available
Logan Health Breast Center
Kalispell, Montana 59901
United States
Site Not Available
Logan Health Breast Center
Kalispell 5660340, Montana 5667009 59901
United States
Site Not Available
Englewood Health
Englewood, New Jersey 07631
United States
Site Not Available
Englewood Health
Englewood 5097672, New Jersey 5101760 07631
United States
Site Not Available
Health and Hospitals Corporation/Kings County
Brooklyn, New York 11203
United States
Site Not Available
Northwell Northern Westchester
Mount Kisco, New York 10549
United States
Site Not Available
Northwell Health
Staten Island, New York 10305
United States
Site Not Available
Health and Hospitals Corporation/Kings County
Brooklyn 5110302, New York 5128638 11203
United States
Site Not Available
Northwell Northern Westchester
Mount Kisco 5127744, New York 5128638 10549
United States
Site Not Available
Northwell Health
Staten Island 5139568, New York 5128638 10305
United States
Site Not Available
Lehigh Valley
Bethlehem, Pennsylvania 18017
United States
Site Not Available
Lehigh Valley
Bethlehem 5180225, Pennsylvania 6254927 18017
United States
Site Not Available

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