HydroMARK Post-market Clinical Follow-up Study

• Sponsor: Devicor Medical Products, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04622696
• Collaborator: (none)
• Enrollment: 832
• Locations: 3
• Anticipated Duration (Months): 33.4
• Patients Per Site: 277.3
• Patients Per Site Per Month: 8.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Diagnostic Test: Ultrasound imaging

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 832 participants
• Observational Model: Other
• Time Perspective: Other
• Official Title: A Post-market Clinical Follow-up Study to Evaluate the Safety and Performance of the HydroMARK® Breast Biopsy Site Marker
• Actual Study Start Date: Feb 16, 2021
• Anticipated Primary Completion Date: Oct 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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; 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).
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).

Outcome Measures

Primary Outcome Measures

1. Safety Cohort [90 days post-implant]

   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.

2. Performance Cohort [6 - 12 weeks post-implant]

   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".

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ohio State University Wexner Medical Center	Columbus	Ohio	United States	43210
2	ProMedica Toledo Hopsital	Toledo	Ohio	United States	43606
3	West Virginia University	Morgantown	West Virginia	United States	26506

Sponsors and Collaborators

• Devicor Medical Products, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Devicor Medical Products, Inc.
• ClinicalTrials.gov Identifier: NCT04622696
• Other Study ID Numbers: LBS-CA-PTL-033
• First Posted: Nov 10, 2020
• Last Update Posted: Apr 26, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Devicor Medical Products, Inc.: Radiology; Breast Biopsy; Ultrasound visibility

Study Results

No Results Posted as of Apr 26, 2022