Status:
COMPLETED
MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery
Lead Sponsor:
Dune Medical Devices
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-90 years
Phase:
NA
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 excisi...
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...
Eligibility Criteria
Inclusion
- Women histologically diagnosed with carcinoma of the breast
- Women with non-palpable malignant lesions, requiring image guided localization.
- Undergoing lumpectomy (partial mastectomy) procedure.
- Age 18 years or more
- Signed ICF
Exclusion
- Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast)
- Bilateral disease (diagnosed cancer in both breasts)
- Neoadjuvant systemic therapy
- Previous radiation in the operated breast
- Prior surgical procedure in the same breast
- Implants in the operated breast
- Pregnancy
- Lactation
- Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
664 Patients enrolled
Trial Details
Trial ID
NCT00749931
Start Date
October 1 2008
End Date
June 1 2010
Last Update
June 27 2014
Active Locations (21)
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1
Pacific Breast Care
Costa Mesa, California, United States, 92627
2
University of Southern California
Los Angeles, California, United States, 90033
3
Cedars Sinai Hospital
Los Angeles, California, United States, 90048
4
HOAG Memorial Hospital
Newport Beach, California, United States, 92658-6100