MarginProbe® System U.S. Post-Approval Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2021-11-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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SOC + Device

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

Group Type OTHER

Margin Probe

Intervention Type DEVICE

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

SOC + Additional Inspection

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

Group Type OTHER

Control: Additional inspection

Intervention Type OTHER

The surgeon will perform additional inspection and assessment of the margins of the main ex-vivo lumpectomy specimen following primary excision

Interventions

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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

Intervention Type DEVICE

Control: Additional inspection

The surgeon will perform additional inspection and assessment of the margins of the main ex-vivo lumpectomy specimen following primary excision

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No