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

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.

Conditions

• Breast Cancer

Interventions

DEVICE

MarginProbe

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

PROCEDURE

Lumpectomy

Standard of care lumpectomy procedure

Sponsors & Collaborators

• Dune Medical Devices

  lead INDUSTRY

Principal Investigators

• Tanir M. Allweis, MD · Hadassah Medical Organization, Israel

• Moshe Carmon, MD · Shaare Zedek Medical Center, Israel

• Tami Karni, MD · Assaf Harefeh Medical Center, Israel

• Alison Estabrook, MD · St. Luke's Roosevelt, NY, USA

• Freya Schnabel, MD · NYU Clinical Cancer Center, NY, USA

• Rache M. Simmons, MD · Weill Medical College of Cornell University, NY, USA

• Sheldon M. Feldman, MD · Columbia University Medical Center, NY, USA

• Mark A. Gittelman, MD · Breast Care Specialist, Allentown, Pennsylvania, USA

• Neil Friedman, MD · Mercy Health Srvices, Baltimore, USA

• Kristen L. Fernandez, MD · Franklin Square Hospital Center, Baltimore, USA

• Shawna C. Willey, MD · Georgetown University Hospital, Washington, USA

• Lorraine Tafra, MD · Anne Arundel Medical Center, Annapolis, USA

• Karen Lane, MD · UCIrvine Medical Center, California, USA

• Jay Harness, MD · St. Joseph Hospital, California, USA

• Alice Police, MD · Pacific Breast Care, California, USA

• Dennis R. Holmes, MD · University of South California, California, USA

• Scott Karlan, MD · Cedars Sinai Hospital, California, USA

• Stephanie Akbari, MD · Virginia Hospital Center

• Thomas Frazier, MD · Bryn Mawr Hospital

• Lisa E. Guerra, MD · HOAG Memorial Hospital

• Susan K. Boolbol, MD · Beth Israel Medical Center, NY, USA

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-10-31

Primary Completion

2010-03-31

Completion

2010-06-30

Countries

• United States
• Israel

Study Locations