HydroMARK Post-market Clinical Follow-up Study

Completed

• Conditions: Breast Cancer
• Interventions: Diagnostic Test: Ultrasound imaging

• Registration Number: NCT04622696
• Lead Sponsor: Devicor Medical Products, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-26
• Study First Submitted QC: 2020-11-04
• Study First Posted: 2020-11-10
• Study Start: 2021-02-16
• Primary Completion: 2023-08-07
• Study Completion: 2023-08-07
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-04
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 730

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective - Performance Cohort	Ultrasound imaging	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.

Primary Outcome Measures

Name	Time	Method
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".
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.

Trial Locations

Locations (3)

ProMedica Toledo Hopsital; 🇺🇸 Toledo, Ohio, United States

Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States

West Virginia University; 🇺🇸 Morgantown, West Virginia, United States