MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery

The purpose of this study is to show that addition of device use to a routine breast cancer tumor excision procedure is beneficial and assists the surgeon in correctly determining the extent of excision.

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Key information

Conditions

Breast Cancer Adenocarcinoma Breast Carcinoma In Situ Breast Diseases Breast Neoplasms Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Haddasah Medical Organization, Jerusalem, Israel

About this study

The study is a prospective, multi-center, randomized, double arm study demonstrating the effectiveness of the device in adjunctive use for locating the tissue for additional excision following primary specimen excision. One arm is a "Standard of Care" (SOC) Control group and the other arm a "Device+SOC" group.In the "Device +SOC" group the surgeon will use the MarginProbe device on the tissue specimen removed during the surgical procedure.The surgeon will use the results derived from the device and other routine assessments to decide if it is necessary to remove some additional breast tissue.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast)
Bilateral disease (diagnosed cancer in both breasts)
Neoadjuvant systemic therapy
Previous radiation in the operated breast
Prior surgical procedure in the same breast
Implants in the operated breast
Pregnancy
Lactation
Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.

Treatment and study plan

MarginProbe

Device

Device use to assess margin status of the excised specimen surface.

Lumpectomy

Procedure

Standard of care lumpectomy procedure

Primary outcomes

The Primary Effectiveness Endpoint is a Measure of Intraoperative Success in Addressing Positive Margins as Detected by Permanent Pathology)by Additional Oriented Tissue Re-excision From the Surgical Cavity.

Time frame: two weeks after surgery

Tests the efficacy of the device to intra-operatively assess positive margins (superiority) - CSR is 'positive' when all positive margins, as detected by histology, on the main specimen addressed intra-operatively

Sponsors and collaborators

Lead sponsor

Dune Medical Devices

Industry

Registry information

Acronym: Pivotal

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Sep 9, 2008
Registry last updated: Jun 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed