Spots Global Cancer Trial Database for MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery
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Trial Identification
Brief Title: MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery
Official Title: MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery
Study ID: NCT00749931
Conditions
Study Description
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.
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Pacific Breast Care, Costa Mesa, California, United States
University of Southern California, Los Angeles, California, United States
Cedars Sinai Hospital, Los Angeles, California, United States
HOAG Memorial Hospital, Newport Beach, California, United States
St. Joseph Hospital, Orange, California, United States
UCIrvine Medical Center, Orange, California, United States
Georgetown University Hospital, Washington, District of Columbia, United States
Anne Arundel Medical Center, Annapolis, Maryland, United States
Mercy Hospital Services, Baltimore, Maryland, United States
Franklin Square Hospital Center, Baltimore, Maryland, United States
Beth Israel Medical Center, New York, New York, United States
NYU Clinical Cancer Center, New York, New York, United States
St. Luke's Roosevelt, New York, New York, United States
Columbia University Medical Center, New York, New York, United States
Weill Medical College of Cornell University, New-York, New York, United States
Breast Care Center, Allentown, Pennsylvania, United States
Bryn Mawr Hospital, Bryn Mawr, Pennsylvania, United States
Virginia Hospital Center, Arlington, Virginia, United States
Haddasah Medical Organization, Jerusalem, , Israel
Shaare Zedek, Jerusalem, , Israel
Assaf Harofeh Medical Center, Zrifin, , Israel
Contact Details
Name: Tanir M. Allweis, MD
Affiliation: Hadassah Medical Organization, Israel
Role: PRINCIPAL_INVESTIGATOR
Name: Moshe Carmon, MD
Affiliation: Shaare Zedek Medical Center, Israel
Role: PRINCIPAL_INVESTIGATOR
Name: Tami Karni, MD
Affiliation: Assaf Harefeh Medical Center, Israel
Role: PRINCIPAL_INVESTIGATOR
Name: Alison Estabrook, MD
Affiliation: St. Luke's Roosevelt, NY, USA
Role: PRINCIPAL_INVESTIGATOR
Name: Freya Schnabel, MD
Affiliation: NYU Clinical Cancer Center, NY, USA
Role: PRINCIPAL_INVESTIGATOR
Name: Rache M. Simmons, MD
Affiliation: Weill Medical College of Cornell University, NY, USA
Role: PRINCIPAL_INVESTIGATOR
Name: Sheldon M. Feldman, MD
Affiliation: Columbia University Medical Center, NY, USA
Role: PRINCIPAL_INVESTIGATOR
Name: Mark A. Gittelman, MD
Affiliation: Breast Care Specialist, Allentown, Pennsylvania, USA
Role: PRINCIPAL_INVESTIGATOR
Name: Neil Friedman, MD
Affiliation: Mercy Health Srvices, Baltimore, USA
Role: PRINCIPAL_INVESTIGATOR
Name: Kristen L. Fernandez, MD
Affiliation: Franklin Square Hospital Center, Baltimore, USA
Role: PRINCIPAL_INVESTIGATOR
Name: Shawna C. Willey, MD
Affiliation: Georgetown University Hospital, Washington, USA
Role: PRINCIPAL_INVESTIGATOR
Name: Lorraine Tafra, MD
Affiliation: Anne Arundel Medical Center, Annapolis, USA
Role: PRINCIPAL_INVESTIGATOR
Name: Karen Lane, MD
Affiliation: UCIrvine Medical Center, California, USA
Role: PRINCIPAL_INVESTIGATOR
Name: Jay Harness, MD
Affiliation: St. Joseph Hospital, California, USA
Role: PRINCIPAL_INVESTIGATOR
Name: Alice Police, MD
Affiliation: Pacific Breast Care, California, USA
Role: PRINCIPAL_INVESTIGATOR
Name: Dennis R. Holmes, MD
Affiliation: University of South California, California, USA
Role: PRINCIPAL_INVESTIGATOR
Name: Scott Karlan, MD
Affiliation: Cedars Sinai Hospital, California, USA
Role: PRINCIPAL_INVESTIGATOR
Name: Stephanie Akbari, MD
Affiliation: Virginia Hospital Center
Role: PRINCIPAL_INVESTIGATOR
Name: Thomas Frazier, MD
Affiliation: Bryn Mawr Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Lisa E. Guerra, MD
Affiliation: HOAG Memorial Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Susan K. Boolbol, MD
Affiliation: Beth Israel Medical Center, NY, USA
Role: PRINCIPAL_INVESTIGATOR
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