MarginProbe® System U.S. Post-Approval Study

Breast Cancer Clinical Trial

Official title: MarginProbe® System U.S. Post-Approval Study Protocol CP-07-001

Status Active, not recruiting

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Breast Cancer

• NCT number: NCT02406599
• Study type: Interventional
• Source: Dune Medical Devices
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2015
• Completion date: November 2021