MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery (Pivotal)

May 26, 2014 updated by: Dune Medical Devices
The purpose of this study is to show that addition of device use to a routine breast cancer tumor excision procedure is beneficial and assists the surgeon in correctly determining the extent of excision.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is a prospective, multi-center, randomized, double arm study demonstrating the effectiveness of the device in adjunctive use for locating the tissue for additional excision following primary specimen excision. One arm is a "Standard of Care" (SOC) Control group and the other arm a "Device+SOC" group.In the "Device +SOC" group the surgeon will use the MarginProbe device on the tissue specimen removed during the surgical procedure.The surgeon will use the results derived from the device and other routine assessments to decide if it is necessary to remove some additional breast tissue.

Study Type

Interventional

Enrollment (Actual)

664

Phase

  • Not Applicable

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
        • Shaare Zedek
      • Jerusalem, Israel
        • Haddasah Medical Organization
      • Zrifin, Israel, 70300
        • Assaf Harofeh Medical Center
  • United States
    • California
      • Costa Mesa, California, United States, 92627
        • Pacific Breast Care
      • Los Angeles, California, United States, 90033
        • University of Southern California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Hospital
      • Newport Beach, California, United States, 92658-6100
        • Hoag Memorial Hospital
      • Orange, California, United States, 92868
        • St. Joseph Hospital
      • Orange, California, United States, 92868
        • UCIrvine Medical Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Hospital
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Anne Arundel Medical Center
      • Baltimore, Maryland, United States, 21237
        • Franklin Square Hospital Center
      • Baltimore, Maryland, United States, 21202
        • Mercy Hospital Services
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10016
        • Nyu Clinical Cancer Center
      • New York, New York, United States, 10003
        • Beth Israel Medical Center
      • New York, New York, United States, 10019
        • St. Luke's Roosevelt
      • New-York, New York, United States, 10021
        • Weill Medical College of Cornell University
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Breast Care Center
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Bryn Mawr Hospital
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Virginia Hospital Center

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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Women histologically diagnosed with carcinoma of the breast
  2. Women with non-palpable malignant lesions, requiring image guided localization.
  3. Undergoing lumpectomy (partial mastectomy) procedure.
  4. Age 18 years or more
  5. Signed ICF

Exclusion Criteria:

  1. Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast)
  2. Bilateral disease (diagnosed cancer in both breasts)
  3. Neoadjuvant systemic therapy
  4. Previous radiation in the operated breast
  5. Prior surgical procedure in the same breast
  6. Implants in the operated breast
  7. Pregnancy
  8. Lactation
  9. 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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SOC
Standard of Care arm - standard of care lumpectomy procedure
Procedure: Lumpectomy
Standard of care lumpectomy procedure
Experimental: Device + SOC
Use of the device in addition to the standard of care lumpectomy procedure.
Procedure: Lumpectomy
Standard of care lumpectomy procedure
Device: MarginProbe
Device use to assess margin status of the excised specimen surface.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Primary Effectiveness Endpoint is a Measure of Intraoperative Success in Addressing Positive Margins as Detected by Permanent Pathology)by Additional Oriented Tissue Re-excision From the Surgical Cavity.
Time Frame: two weeks after surgery
Tests the efficacy of the device to intra-operatively assess positive margins (superiority) - CSR is 'positive' when all positive margins, as detected by histology, on the main specimen addressed intra-operatively
two weeks after surgery

Collaborators and Investigators

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

Sponsor

Dune Medical Devices

Investigators

  • Principal Investigator: Tanir M. Allweis, MD, Hadassah Medical Organization, Israel
  • Principal Investigator: Moshe Carmon, MD, Shaare Zedek Medical Center, Israel
  • Principal Investigator: Tami Karni, MD, Assaf Harefeh Medical Center, Israel
  • Principal Investigator: Alison Estabrook, MD, St. Luke's Roosevelt, NY, USA
  • Principal Investigator: Freya Schnabel, MD, NYU Clinical Cancer Center, NY, USA
  • Principal Investigator: Rache M. Simmons, MD, Weill Medical College of Cornell University, NY, USA
  • Principal Investigator: Sheldon M. Feldman, MD, Columbia University Medical Center, NY, USA
  • Principal Investigator: Mark A. Gittelman, MD, Breast Care Specialist, Allentown, Pennsylvania, USA
  • Principal Investigator: Neil Friedman, MD, Mercy Health Srvices, Baltimore, USA
  • Principal Investigator: Kristen L. Fernandez, MD, Franklin Square Hospital Center, Baltimore, USA
  • Principal Investigator: Shawna C. Willey, MD, Georgetown University Hospital, Washington, USA
  • Principal Investigator: Lorraine Tafra, MD, Anne Arundel Medical Center, Annapolis, USA
  • Principal Investigator: Karen Lane, MD, UCIrvine Medical Center, California, USA
  • Principal Investigator: Jay Harness, MD, St. Joseph Hospital, California, USA
  • Principal Investigator: Alice Police, MD, Pacific Breast Care, California, USA
  • Principal Investigator: Dennis R. Holmes, MD, University of South California, California, USA
  • Principal Investigator: Scott Karlan, MD, Cedars Sinai Hospital, California, USA
  • Principal Investigator: Stephanie Akbari, MD, Virginia Hospital Center
  • Principal Investigator: Thomas Frazier, MD, Bryn Mawr Hospital
  • Principal Investigator: Lisa E. Guerra, MD, Hoag Memorial Hospital
  • Principal Investigator: Susan K. Boolbol, MD, Beth Israel Medical Center, NY, USA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

October 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

September 7, 2008

First Submitted That Met QC Criteria

September 7, 2008

First Posted (Estimate)

September 9, 2008

Study Record Updates

Last Update Posted (Estimate)

June 27, 2014

Last Update Submitted That Met QC Criteria

May 26, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CP-03-001

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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