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

Dune Medical Devices664 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

664

Conditions

Breast Cancer

Interventions

MarginProbeDEVICE

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

LumpectomyPROCEDURE

Standard of care lumpectomy procedure

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (21)

Pacific Breast Care

Costa Mesa, California, United States

University of Southern California

Outcomes

Primary Outcomes

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

Time frame: two weeks after surgery

Data from ClinicalTrials.gov

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