Clinical trial NCT04622696: HydroMARK Post-market Clinical Follow-up Study
Official title: A Post-market Clinical Follow-up Study to Evaluate the Safety and Performance of the HydroMARK® Breast Biopsy Site Marker
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Radiology
Breast Biopsy
Ultrasound visibility
Lead sponsor: Leica Biosystems
Sponsor class: INDUSTRY
First posted: 2020-11-10
Enrollment: 730
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety Cohort
timeFrame: 90 days post-implant
measure: Performance Cohort
timeFrame: 6 - 12 weeks post-implant
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
city: Toledo
country: United States
facility: ProMedica Toledo Hopsital
state: Ohio
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
References: