Improved Successful Retrieval Rate of HydroMARK Plus Breast Biopsy Site Marker in Comparison to HydroMARK as Well as Improved Surgeon Satisfaction

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06294574
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • HydroMARK Plus Clip — DEVICE
    Each patient will undergo a breast localization procedure, and a HydroMARK plus clip will be placed.

Study Details

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.

Key Dates

Start date
Aug 5, 2025
Status verified
Sep 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 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.

Primary Outcome Measure

Retrieval rate of the HydroMARK Plus clip. [ Time Frame: Date of HydroMARK Plus Clip placement to 1 week plus or minus 5 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Kirklin ClinicBirminghamAlabama35249
Quenteeria Mooney
[email protected]
205-996-1082
Ceren Yalniz, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
The Kirklin Clinic· Birmingham, AL

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