HydroMARK Post-market Clinical Follow-up Study

Devicor Medical Products

Status: Completed

Conditions: Breast Cancer

Treatments: Diagnostic Test: Ultrasound imaging

Study type: Observational

Funder types: Industry

Identifiers

NCT04622696

LBS-CA-PTL-033

Details and patient eligibility

About

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.

Enrollment: 730 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

730 participants in 2 patient groups

Prospective - Performance Cohort

Description:

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.

Treatment:

Diagnostic Test: Ultrasound imaging

Retrospective - Safety Cohort

Description:

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).