NCT02406599

MarginProbe® System U.S. Post-Approval Study

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 440 (estimated)
• Sponsor: Dune Medical Devices · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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	Control: Additional inspection	The surgeon will perform additional inspection and assessment of the margins of the main ex-vivo lumpectomy specimen following primary excision

Timeline

• Start date: 2015-06-01
• Primary completion: 2021-09-01
• Completion: 2021-11-01
• First posted: 2015-04-02
• Last updated: 2021-08-18

Locations

11 sites across 1 country: United States