Breast Cancer
Conditions
Keywords
Radiology, Breast Biopsy, Ultrasound visibility
Brief summary
The purpose of this study is to assess the safety and performance of the HydroMARK Breast Biopsy Site Marker manufactured in the Devicor Medical Products, Inc. Tijuana facility.
Interventions
DIAGNOSTIC_TESTUltrasound 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).
Sponsors
Devicor Medical Products, Inc.
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Cohort | 90 days post-implant | The safety cohort will consist of approximately 491 evaluable subject medical records reviewed retrospectively from patients followed for a minimum of 90 days post-implant unless the subject was exited according to the medical records due to the implant being removed/explanted or subject death. Device-related adverse events and device deficiencies will be collected. |
| Performance Cohort | 6 - 12 weeks post-implant | The performance cohort will prospectively enroll approximately 341 subjects with a suspected breast cancer that will undergo as part of standard of care an ultrasound-guided breast biopsy procedure, including placement of HydroMARK, with an aim of achieving a minimum 239 evaluable subjects (assuming 30% attrition rate due to surgical excision prior to follow-up, lost to follow-up, death) returning to the office at 6-12 weeks for ultrasound imaging to evaluate HydroMARK visibility. The visibility rate will be dichotomized into two categories from rankings using a 1-5 Likert-type scale - 1 no/inadequate visibility and 2 slightly visible, 3 moderately visible, 4 very visible and 5 extremely visible will be coalesced into a single category of being visible. |
Countries
United States
Outcome results
None listed