Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Devicor Medical Products, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Safety Cohort
Subject was implanted during a breast biopsy procedure with a HydroMARK Breast Biopsy Site Marker manufactured at the Devicor Tijuana facility per the instructions for use
Subject has been followed at least 90 days according to the hospital's standard of care (SOC)
Subject was ≥ 18 years of age at the time of the breast biopsy procedure
Subject has accessible medical records documenting the breast biopsy procedure including, at minimum: age, sex, primary diagnostic indication and documentation of device-related adverse events which occurred, if any
Performance Cohort
Subject was implanted during a breast biopsy procedure with a HydroMARK Breast Biopsy Site Marker manufactured at the Devicor Tijuana facility per the instructions for use
Patient is ≥18 years of age
Patient has provided informed consent to participate in study, including follow-up visit for ultrasound imaging at 6-12 weeks post-biopsy
You may not be if
Safety Cohort
Biopsy area was infected at the time of implant
Performance Cohort
Contraindication to HydroMARK Breast Biopsy Site Marker implantation
Biopsy area is infected at the time of implant
Patient has a breast biopsy marker (in the same breast) implanted from a previous procedure
