MarginProbe 2.0 Data Collection Protocol

August 27, 2025 updated by: Dilon Medical Technologies Ltd.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

398

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah Medical Organization
  • United States
    • California
      • Glendale, California, United States, 91206
        • Glendale Adventist Medical Center
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403
        • Mercy Medical Center
    • Montana
      • Kalispell, Montana, United States, 59901
        • Logan Health Breast Center
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Englewood Health
    • New York
      • Brooklyn, New York, United States, 11203
        • Health and Hospitals Corporation/Kings County
      • Mount Kisco, New York, United States, 10549
        • Northwell Northern Westchester
      • Staten Island, New York, United States, 10305
        • Northwell Health
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
        • LeHigh Valley

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study will include measurements in cohorts of a minimum of 50 subjects up to a maximum of 1000 cases from women, aged 18 and above, undergoing breast lumpectomy/partial mastectomy surgery for previously diagnosed breast cancer.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Undergoing re-excision procedure
  2. Concurrent infectious disease
  3. Pregnancy
  4. Lactation
  5. Previous surgery in the same site including open biopsy procedure, previous breast reduction or mastopexy in the operated breast
  6. Prior radiation treatment in the operated breast
  7. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: During the lumpectomy surgery
Adverse Events (AEs) and Serious Adverse Events (SAEs)
During the lumpectomy surgery
Collect MP2.0 data in cohorts of a minimum of 50 subjects to optimize MP2.0 algorithm and procedure.
Time Frame: During the lumpectomy surgery
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.
During the lumpectomy surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dilon Medical Technologies Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2021

Primary Completion (Actual)

August 23, 2024

Study Completion (Actual)

January 12, 2025

Study Registration Dates

First Submitted

May 9, 2022

First Submitted That Met QC Criteria

May 12, 2022

First Posted (Actual)

May 17, 2022

Study Record Updates

Last Update Posted (Estimated)

August 28, 2025

Last Update Submitted That Met QC Criteria

August 27, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-13-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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