HydroMARK Post-market Clinical Follow-up Study

Study Overview
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Brief Summary
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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.

Official Title
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A Post-market Clinical Follow-up Study to Evaluate the Safety and Performance of the HydroMARK® Breast Biopsy Site Marker

Conditions
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Breast Cancer

Intervention / Treatment
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* Diagnostic Test: Ultrasound imaging


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective - Performance Cohort<br>Subjects will undergo an ultrasound-guided breast biopsy procedure with placement of HydroMARK Breast Biopsy Site Marker per site standard of care and will return to the office at 6-12 weeks post-implant for ultrasound imaging to evaluate device visibility. | Diagnostic Test: Ultrasound imaging<br>* 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).<br>|
| Retrospective - Safety Cohort<br>Device-related adverse events will be collected via retrospective medical chart review for a minimum of 90 days post-HydroMARK Breast Biopsy Site Marker implant (unless the subject was exited according to the medical records due to the implant being removed/explanted or subject death). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Cohort | 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. | 90 days post-implant | 
| Performance Cohort | 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. | 6 - 12 weeks post-implant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiology, Breast Biopsy, Ultrasound visibility