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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

NCT04622696•Devicor Medical Products, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (3)

Ohio State University Wexner Medical Center

Columbus, Ohio, United States

ProMedica Toledo Hopsital

Toledo, Ohio, United States

West Virginia University

Morgantown, West Virginia, United States

Key Dates

Start Date

February 16, 2021

Primary Completion Date

August 7, 2023

Completion Date

August 7, 2023

Last Updated

January 5, 2024

Enrollment

730

ACTUAL participants

Conditions

Breast Cancer

Interventions

Ultrasound imaging

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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HydroMARK Post-market Clinical Follow-up Study

Inclusion Criteria

Exclusion Criteria

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