NCT00749931

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 664 (actual)
• Sponsor: Dune Medical Devices · Industry
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	MarginProbe	Device use to assess margin status of the excised specimen surface.
PROCEDURE	Lumpectomy	Standard of care lumpectomy procedure

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-03-01
• Completion: 2010-06-01
• First posted: 2008-09-09
• Last updated: 2014-06-27
• Results posted: 2014-06-27

Locations

21 sites across 2 countries: United States, Israel