MarginProbe® System U.S. Post-Approval Study

NAUnknownINTERVENTIONAL
Enrollment

440

Participants

Timeline

Start Date

June 30, 2015

Primary Completion Date

September 30, 2021

Study Completion Date

November 30, 2021

Conditions
Breast Cancer
Interventions
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

Trial Locations (11)

10461

Montefiore Medical Center, New York

17109

PinnacleHealth Cancer Institute, Harrisburg

20016

Sibley Memorial Hospital, Washington D.C.

20817

Suburban Hospital, Bethesda

21287

John Hopkins Medicine, Baltimore

32207

Baptist MD Anderson Cancer Center, Jacksonville

33612

Moffitt Cancer Center, Tampa

60201

NorthShore University HealthSystem, Chicago

60612

Rush University Medical Center, Chicago

87102

New Mexico University Cancer center, Albuquerque

07922

Summit Medical Group, Berkeley Heights

Sponsors
All Listed Sponsors
lead

Dune Medical Devices

INDUSTRY