MarginProbe 2.0 Data Collection Protocol

Last updated: November 24, 2024
Sponsor: Dilon Medical Technologies Ltd.
Overall Status: Active - Not Recruiting

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:

  1. Women over 18 years of age

  2. Diagnosed with cancer, undergoing lumpectomy or partial mastectomy procedure

  3. Signed Informed Consent Form

Exclusion

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 breastreduction 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 caninfluence collection of valid data under this study

Study Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: MarginProbe2.0
Phase:
Study Start date:
December 15, 2021
Estimated Completion Date:
January 31, 2025

Connect with a study center

  • Hadassah Medical Organization

    Jerusalem, 91120
    Israel

    Site Not Available

  • Glendale Adventist Medical Center

    Glendale, California 91206
    United States

    Site Not Available

  • Mercy Medical Center

    Cedar Rapids, Iowa 52403
    United States

    Site Not Available

  • Logan Health Breast Center

    Kalispell, Montana 59901
    United States

    Site Not Available

  • Englewood Health

    Englewood, New Jersey 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

  • Lehigh Valley

    Bethlehem, Pennsylvania 18017
    United States

    Site Not Available

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