MarginProbe 2.0 Data Collection Protocol

Completed

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT05377229

Run by

Dilon Medical Technologies Ltd.

People needed

398

Starts

2021-12-15

Expected to finish

2025-01-12

Last updated by the study team

2025-08-28

Who can join

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

You may qualify if…

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

You may not qualify if…

• Undergoing re-excision procedure
• Concurrent infectious disease
• Pregnancy
• Lactation
• Previous surgery in the same site including open biopsy procedure, previous breast reduction 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 can influence collection of valid data under this study

Where it is running

• 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

Full record on ClinicalTrials.gov

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