HydroMARK Post-market Clinical Follow-up Study

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04622696
• Other study ID #: LBS-CA-PTL-033
• Status: Completed
• Start date: February 16, 2021
• Est. completion date: August 7, 2023

Study information

• Verified date: January 2024
• Source: Leica Biosystems
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 730
• Est. completion date: August 7, 2023
• Est. primary completion date: August 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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).

Locations

Country	Name	City	State
United States	Ohio State University Wexner Medical Center	Columbus	Ohio
United States	West Virginia University	Morgantown	West Virginia
United States	ProMedica Toledo Hopsital	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Devicor Medical Products, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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