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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dune Medical Devices
ClinicalTrials.gov Identifier:
NCT00749931
First received: September 7, 2008
Last updated: May 26, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Device: MarginProbe
Procedure: Lumpectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery

Resource links provided by NLM:


Further study details as provided by Dune Medical Devices:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Enrollment: 664
Study Start Date: October 2008
Study Completion Date: June 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: MarginProbe
Device use to assess margin status of the excised specimen surface.
Procedure: Lumpectomy
Standard of care lumpectomy procedure

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00749931

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

Additional Information:
Publications:
Responsible Party: Dune Medical Devices
ClinicalTrials.gov Identifier: NCT00749931     History of Changes
Other Study ID Numbers: CP-03-001
Study First Received: September 7, 2008
Results First Received: May 26, 2014
Last Updated: May 26, 2014
Health Authority: United States: Food and Drug Administration
Israel: Ministry of Health

Keywords provided by Dune Medical Devices:
IDC, DCIS, ILC

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014