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

Dune Medical Devices

Status: Completed

Conditions: Breast Cancer

Treatments: Procedure: Lumpectomy; Device: MarginProbe

Study type: Interventional

Funder types: Industry

Identifiers

NCT00749931

CP-03-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 664 patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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664 participants in 2 patient groups

SOC

Active Comparator group

Description:

Standard of Care arm - standard of care lumpectomy procedure

Treatment:

Procedure: Lumpectomy

Device + SOC

Experimental group

Description:

Use of the device in addition to the standard of care lumpectomy procedure.

Treatment:

Procedure: Lumpectomy

Device: MarginProbe