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HydroMARK Post-market Clinical Follow-up Study

NCT04622696 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 730

Last updated 2024-01-05

No results posted yet for this study

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.

Conditions

Interventions

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).

Sponsors & Collaborators

  • Devicor Medical Products, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-16
Primary Completion
2023-08-07
Completion
2023-08-07
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04622696 on ClinicalTrials.gov