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

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ClinicalTrials.gov Identifier: NCT00749931
Recruitment Status : Completed
First Posted : September 9, 2008
Results First Posted : June 27, 2014
Last Update Posted : June 27, 2014
Sponsor:
Information provided by (Responsible Party):
Dune Medical Devices

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Device: MarginProbe Procedure: Lumpectomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 664 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery
Study Start Date : October 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : June 2010


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.
Device: MarginProbe
Device use to assess margin status of the excised specimen surface.

Procedure: Lumpectomy
Standard of care lumpectomy procedure




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00749931


Locations
Show Show 21 study locations
Sponsors and Collaborators
Dune Medical Devices
Investigators
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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
Additional Information:
Publications of Results:
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Responsible Party: Dune Medical Devices
ClinicalTrials.gov Identifier: NCT00749931    
Other Study ID Numbers: CP-03-001
First Posted: September 9, 2008    Key Record Dates
Results First Posted: June 27, 2014
Last Update Posted: June 27, 2014
Last Verified: May 2014
Keywords provided by Dune Medical Devices:
IDC, DCIS, ILC