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

Breast Cancer Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer

• NCT number: NCT00749931
• Study type: Interventional
• Source: Dune Medical Devices
• Status: Completed
• Phase: N/A
• Start date: October 2008
• Completion date: June 2010