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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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.