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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

664 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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SOC

Standard of Care arm - standard of care lumpectomy procedure

Group Type ACTIVE_COMPARATOR

Lumpectomy

Intervention Type PROCEDURE

Standard of care lumpectomy procedure

Device + SOC

Use of the device in addition to the standard of care lumpectomy procedure.

Group Type EXPERIMENTAL

MarginProbe

Intervention Type DEVICE

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

Lumpectomy

Intervention Type PROCEDURE

Standard of care lumpectomy procedure

Interventions

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MarginProbe

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

Intervention Type DEVICE

Lumpectomy

Standard of care lumpectomy procedure

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tanir M. Allweis, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization, Israel

Moshe Carmon, MD

Role: PRINCIPAL_INVESTIGATOR

Shaare Zedek Medical Center, Israel

Tami Karni, MD

Role: PRINCIPAL_INVESTIGATOR

Assaf Harefeh Medical Center, Israel

Alison Estabrook, MD

Role: PRINCIPAL_INVESTIGATOR

St. Luke's Roosevelt, NY, USA

Freya Schnabel, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Clinical Cancer Center, NY, USA

Rache M. Simmons, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University, NY, USA

Sheldon M. Feldman, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University Medical Center, NY, USA

Mark A. Gittelman, MD

Role: PRINCIPAL_INVESTIGATOR

Breast Care Specialist, Allentown, Pennsylvania, USA

Neil Friedman, MD

Role: PRINCIPAL_INVESTIGATOR

Mercy Health Srvices, Baltimore, USA

Kristen L. Fernandez, MD

Role: PRINCIPAL_INVESTIGATOR

Franklin Square Hospital Center, Baltimore, USA

Shawna C. Willey, MD

Role: PRINCIPAL_INVESTIGATOR

Georgetown University Hospital, Washington, USA

Lorraine Tafra, MD

Role: PRINCIPAL_INVESTIGATOR

Anne Arundel Medical Center, Annapolis, USA

Karen Lane, MD

Role: PRINCIPAL_INVESTIGATOR

UCIrvine Medical Center, California, USA

Jay Harness, MD

Role: PRINCIPAL_INVESTIGATOR

St. Joseph Hospital, California, USA

Alice Police, MD

Role: PRINCIPAL_INVESTIGATOR

Pacific Breast Care, California, USA

Dennis R. Holmes, MD

Role: PRINCIPAL_INVESTIGATOR

University of South California, California, USA

Scott Karlan, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars Sinai Hospital, California, USA

Stephanie Akbari, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Hospital Center

Thomas Frazier, MD

Role: PRINCIPAL_INVESTIGATOR

Bryn Mawr Hospital

Lisa E. Guerra, MD

Role: PRINCIPAL_INVESTIGATOR

HOAG Memorial Hospital

Susan K. Boolbol, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Medical Center, NY, USA

Locations

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Pacific Breast Care

Costa Mesa, California, United States

Site Status

University of Southern California

Los Angeles, California, United States

Site Status

Cedars Sinai Hospital

Los Angeles, California, United States

Site Status

HOAG Memorial Hospital

Newport Beach, California, United States

Site Status

St. Joseph Hospital

Orange, California, United States

Site Status

UCIrvine Medical Center

Orange, California, United States

Site Status

Georgetown University Hospital

Washington D.C., District of Columbia, United States

Site Status

Anne Arundel Medical Center

Annapolis, Maryland, United States

Site Status

Mercy Hospital Services

Baltimore, Maryland, United States

Site Status