Clinical trial · Observational
HydroMARK Post-market Clinical Follow-up Study
A Post-market Clinical Follow-up Study to Evaluate the Safety and Performance of the HydroMARK® Breast Biopsy Site Marker
NCT04622696CI-TRIAL-00072766completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ultrasound imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 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.
- interventionNames
- Diagnostic Test: Ultrasound imaging
- label
- 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).
Primary outcomes (2)
- measure
- Safety Cohort
- timeFrame
- 90 days post-implant
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.