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

Breast Cancer Clinical Trial

— Pivotal  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00749931
• Other study ID #: CP-03-001
• Status: Completed
• Phase: N/A
• First received: September 7, 2008
• Last updated: May 26, 2014
• Start date: October 2008
• Est. completion date: June 2010

Study information

• Verified date: May 2014
• Source: Dune Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 664
• Est. completion date: June 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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

Procedure:
• Lumpectomy
Standard of care lumpectomy procedure

Locations

Country	Name	City	State
Israel	Haddasah Medical Organization	Jerusalem
Israel	Shaare Zedek	Jerusalem
Israel	Assaf Harofeh Medical Center	Zrifin
United States	Breast Care Center	Allentown	Pennsylvania
United States	Anne Arundel Medical Center	Annapolis	Maryland
United States	Virginia Hospital Center	Arlington	Virginia
United States	Franklin Square Hospital Center	Baltimore	Maryland
United States	Mercy Hospital Services	Baltimore	Maryland
United States	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania
United States	Pacific Breast Care	Costa Mesa	California
United States	Cedars Sinai Hospital	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	Beth Israel Medical Center	New York	New York
United States	Columbia University 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	Weill Medical College of Cornell University	New-York	New York
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

Sponsors (1)

Lead Sponsor	Collaborator
Dune Medical Devices

Countries where clinical trial is conducted

United States,  Israel, 

References & Publications (1)

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 s — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	two weeks after surgery	No

External Links

•   Dune Medical Devices official web site