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 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

Recruiting Locations

Montefiore Medical Center
New York, New York 10461
Contact:
Melissa Suarez
718-920-6742
mesuarez@montefiore.org

More Details

NCT ID
NCT02406599
Status
Recruiting
Sponsor
Dune Medical Devices

Study Contact

Robin Fatzinger
6109843569
robin.fatzinger@dunemedical.com

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.