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

September 7, 2008
May 26, 2014
October 2008
March 2010   (final data collection date for primary outcome measure)
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
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 ]
Complete list of historical versions of study NCT00749931 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery
MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Breast Cancer
  • Device: MarginProbe
    Device use to assess margin status of the excised specimen surface.
  • Procedure: Lumpectomy
    Standard of care lumpectomy procedure
  • Active Comparator: SOC
    Standard of Care arm - standard of care lumpectomy procedure
    Intervention: Procedure: Lumpectomy
  • Experimental: Device + SOC
    Use of the device in addition to the standard of care lumpectomy procedure.
    Interventions:
    • Device: MarginProbe
    • Procedure: Lumpectomy
Schnabel F, Boolbol SK, Gittleman M, Karni T, Tafra L, Feldman S, Police A, Friedman NB, Karlan S, Holmes D, Willey SC, Carmon M, Fernandez K, Akbari S, Harness J, Guerra L, Frazier T, Lane K, Simmons RM, Estabrook A, Allweis T. A randomized prospective study of lumpectomy margin assessment with use of MarginProbe in patients with nonpalpable breast malignancies. Ann Surg Oncol. 2014 May;21(5):1589-95. doi: 10.1245/s10434-014-3602-0. Epub 2014 Mar 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
664
June 2010
March 2010   (final data collection date for primary outcome measure)

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.
Female
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Israel
 
NCT00749931
CP-03-001
No
Dune Medical Devices
Dune Medical Devices
Not Provided
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
Dune Medical Devices
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP