HydroMARK Post-market Clinical Follow-up Study

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Diagnostic test: Ultrasound imaging

• Study Type: Observational
• Enrollment (Actual): 730

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Wexner Medical Center
    • Toledo, Ohio, United States, 43606
      • ProMedica Toledo Hopsital
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Safety cohort: retrospective chart review of ~491 subjects who underwent a breast biopsy procedure with implant of a HydroMARK Breast Biopsy Site Marker manufactured at the Devicor Tijuana facility.

Performance cohort: ~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 Breast Biopsy Site Marker manufactured at the Devicor Tijuana facility, with an aim of achieving a minimum 239 evaluable subjects returning to the office at 6-12 weeks for ultrasound imaging to evaluate device visibility.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prospective - Performance Cohort; 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; 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).
Retrospective - Safety Cohort; 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?

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

Collaborators and Investigators

• Sponsor: Devicor Medical Products, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2021
• Primary Completion (Actual): August 7, 2023
• Study Completion (Actual): August 7, 2023

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: November 4, 2020
• First Posted (Actual): November 10, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Radiology; Breast Biopsy; Ultrasound visibility
• Other Study ID Numbers: LBS-CA-PTL-033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No