HydroMARK Post-market Clinical Follow-up Study

NCT04622696 | Completed DMC FDA Device

• 1 other identifier: LBS-CA-PTL-033
• Study Type: observational
• Target: 730
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Cancer

Keywords

Radiology; Breast Biopsy; Ultrasound visibility

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

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).

Interventions

Ultrasound imaging DIAGNOSTIC_TEST

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).

Prospective - Performance Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Devicor Medical Products, Inc.: lead

Study Sites (3)

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

ProMedica Toledo Hopsital

Toledo, Ohio, 43606, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 6 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 10, 2020
• Study Start: February 16, 2021
• Primary Completion: August 7, 2023
• Study Completion: August 7, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)