Improved Successful Retrieval Rate of HydroMARK Plus Breast Biopsy Site Marker in Comparison to HydroMARK as Well as Improved Surgeon Satisfaction
NCT ID: NCT06294574
Last Updated: 2025-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2025-08-05
2027-12-31
Brief Summary
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Detailed Description
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Primary objective
Assess the successful retrieval rates of the HydroMARK Plus clip
Secondary objective
Determine the level of satisfaction of the surgeon with the retrieval of the HydroMARK Plus clip
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Hydromark plus clip placement
Patients 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.
HydroMARK Plus Clip
Each patient will undergo a breast localization procedure, and a HydroMARK plus clip will be placed.
Interventions
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HydroMARK Plus Clip
Each patient will undergo a breast localization procedure, and a HydroMARK plus clip will be placed.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients older than 90 years old
* Inmates
* Non-English speakers
18 Years
90 Years
FEMALE
No
Sponsors
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Mammotome
UNKNOWN
University of Alabama at Birmingham
OTHER
Responsible Party
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Ceren Yalniz
Assistant Professor
Principal Investigators
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Ceren Yalniz, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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The Kirklin Clinic
Birmingham, Alabama, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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000544990
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
300011943
Identifier Type: -
Identifier Source: org_study_id
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