Improved Successful Retrieval Rate of HydroMARK Plus Breast Biopsy Site Marker in Comparison to HydroMARK as Well as Improved Surgeon Satisfaction
2 other identifiers
interventional
150
1 country
1
Brief Summary
The purpose of the study is to test how successful the retrieval rate of the new HydroMARK Plus Breast Biopsy Site Marker in comparison to HydroMARK.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2024
CompletedFirst Posted
Study publicly available on registry
March 5, 2024
CompletedStudy Start
First participant enrolled
August 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
September 22, 2025
September 1, 2025
2.3 years
February 28, 2024
September 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Retrieval rate of the HydroMARK Plus clip.
The primary endpoint of HydroMARK Plus retrieval rate will be estimated with % and two-sided 95% CI using normal approximation. A paired McNemar Test will be used to compare HydroMARK Plus retrieval rate and HydroMARK retrieval rate, and the 95% CI for the difference of retrieve rate will be estimated using the Newcombe's Score method.
Date of HydroMARK Plus Clip placement to 1 week plus or minus 5 days
Secondary Outcomes (1)
Level of satisfaction of the surgeon with the retrieval of the HydroMARK Plus clip.
Date of retrieval surgery to 1 week.
Study Arms (1)
Hydromark plus clip placement
EXPERIMENTALPatients with a previously placed HydroMARK T3 coil clip or a clip made by another manufacturer and will have a HydroMARK Plus clip placed during the scout localization procedure for this study. Breast surgeons will perform retrieval and then complete a satisfaction survey to compare the two clips.
Interventions
Each patient will undergo a breast localization procedure, and a HydroMARK plus clip will be placed.
Eligibility Criteria
You may qualify if:
- Patients with biopsy clips scheduled for surgery with SCOUT localization
You may not qualify if:
- Patients who didn't have surgery, patients younger than 18 years old
- Patients older than 90 years old
- Inmates
- Non-English speakers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Alabama at Birminghamlead
- Mammotomecollaborator
Study Sites (1)
The Kirklin Clinic
Birmingham, Alabama, 35249, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ceren Yalniz, MD
University of Alabama at Birmingham
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 28, 2024
First Posted
March 5, 2024
Study Start
August 5, 2025
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
September 22, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share