MarginProbe® System U.S. Post-Approval Study

Purpose

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

Condition

  • Breast Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Other
SOC + Device 		The surgeon will perform routine standard of care lumpectomy with adjunctive MarginProbe device use on the main ex-vivo lumpectomy specimen.
  • Device: Margin Probe
    The surgeon will use the MarginProbe System to identify cancerous tissue at the margins (≤ 1mm) of the main ex-vivo lumpectomy specimen following primary excision
Other
SOC + Additional Inspection 		The surgeon will perform routine standard of care lumpectomy with additional inspection on the main ex-vivo lumpectomy specimen.
  • Other: Control: Additional inspection
    The surgeon will perform additional inspection and assessment of the margins of the main ex-vivo lumpectomy specimen following primary excision

More Details

Status
Unknown status
Sponsor
Dune Medical Devices

Study Contact

Detailed 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.