MarginProbe® System U.S. Post-Approval Study

Dune Medical Devices

Status: Unknown

Conditions: Breast Cancer

Treatments: Device: Margin Probe; Other: Control: Additional inspection

Study type: Interventional

Funder types: Industry

Identifiers

NCT02406599

CP-07-001

Details and patient eligibility

About

The study objective is to determine the MarginProbe® System's diagnostic accuracy at the margin level and impact on Positive Margin* Presence originating from the Main ex-vivo lumpectomy specimen after the initial lumpectomy surgery.

*A positive margin is defined in this study as a margin microscopically measured and reported in the histology report to have cancer within 1 mm or less of the inked surface

Full description

This is a prospective, multicenter, randomized (1:1), double arm, controlled study, in which subjects undergoing breast excision (lumpectomy) for carcinoma of the breast will be randomized to either standard of care with additional inspection ('SOC + Additional inspection' arm) or standard of care with MarginProbe as an adjunct ('SOC + Device' arm).

The MarginProbe is an adjunctive diagnostic tool for identification of cancerous tissue at the margins (≤ 1mm) of the main ex-vivo lumpectomy specimen following primary excision. It will be used by the surgeon during lumpectomy procedures only in patients randomized to the "Device+SOC" arm.

Randomization will take place following the excision of the main ex-vivo lumpectomy specimen.

Enrollment: 440 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• Multi-centric disease (histologically diagnosed cancer in two different quadrants of the breast)
• Bilateral disease (diagnosed cancer in both breasts)
• Neo-adjuvant systemic therapy
• Previous radiation in the operated breast
• Prior surgery in the same site in the breast
• Woman histologically diagnosed by an open biopsy procedure
• Implants in the operated breast
• Pregnancy
• Lactation
• Participating in any other investigational study for either drug or device which could influence collection of valid data under this study
• Patients for whom complete cavity shaving is planned (sites where this is the routine practice of the investigator will also be excluded from participation in the study)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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440 participants in 2 patient groups

SOC + Device

Other group

Description:

The surgeon will perform routine standard of care lumpectomy with adjunctive MarginProbe device use on the main ex-vivo lumpectomy specimen.

Treatment:

Device: Margin Probe

SOC + Additional Inspection

Other group

Description:

The surgeon will perform routine standard of care lumpectomy with additional inspection on the main ex-vivo lumpectomy specimen.

Treatment:

Other: Control: Additional inspection