HydroMARK Post-market Clinical Follow-up Study

CompletedOBSERVATIONAL
Enrollment

730

Participants

Timeline

Start Date

February 16, 2021

Primary Completion Date

August 7, 2023

Study Completion Date

August 7, 2023

Conditions
Breast Cancer
Interventions
DIAGNOSTIC_TEST

Ultrasound imaging

Subjects in the performance cohort will undergo ultrasound imaging to assess the visibility of the HydroMARK Breast Biopsy Marker at 6-12 weeks post-implant. There is no intervention in the safety cohort (retrospective chart review).

Trial Locations (3)

26506

West Virginia University, Morgantown

43210

Ohio State University Wexner Medical Center, Columbus

43606

ProMedica Toledo Hopsital, Toledo

Sponsors
All Listed Sponsors
lead

Devicor Medical Products, Inc.

INDUSTRY