Actively Recruiting
Improved Successful Retrieval Rate of HydroMARK Plus Breast Biopsy Site Marker Compared to HydroMARK and Surgeon Satisfaction
Led by University of Alabama at Birmingham · Updated on 2025-09-22
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
M
Mammotome
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the success of a new breast biopsy site marker called HydroMARK Plus compared to the existing HydroMARK marker. The study aims to measure how often the HydroMARK Plus marker is successfully retrieved and to assess how satisfied surgeons are with retrieving this new clip during breast surgery for patients with breast neoplasm. During the study, patients who have previously had a HydroMARK T3 coil clip or a clip from another manufacturer will receive a HydroMARK Plus clip placed during a breast localization procedure. Breast surgeons will then perform the marker retrieval during surgery and complete a survey to compare their satisfaction with the HydroMARK Plus clip versus previous markers. Participants will be involved from the time of the HydroMARK Plus clip placement until about one week after surgery. Researchers will monitor the retrieval success rate of the HydroMARK Plus clip within this timeframe. They will also collect surgeon satisfaction data one week after the retrieval surgery to evaluate the new marker. The total study duration for each participant spans from clip placement through the short follow-up period after surgery.
CONDITIONS
Brief Title
Improved Successful Retrieval Rate of HydroMARK Plus Breast Biopsy Site Marker in Comparison to HydroMARK as Well as Improved Surgeon Satisfaction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with biopsy clips scheduled for surgery with SCOUT localization
- Female patients
- Age between 18 and 90 years
- Able to understand and communicate in English
You will not qualify if you...
- Patients who did not have surgery
- Patients younger than 18 years old
- Patients older than 90 years old
- Inmates
- Non-English speakers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of placement
Participants undergo a breast localization procedure where a HydroMARK Plus clip is placed.
1 visit (in-person)
Duration - Within 1 week after clip placement
Breast surgeons perform retrieval of the HydroMARK Plus clip and complete a satisfaction survey regarding the retrieval process.
1 visit (in-person)
Duration - 1 week after retrieval surgery
Surgeon satisfaction with the retrieval of the HydroMARK Plus clip is assessed.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
The Kirklin Clinic
Birmingham, Alabama, United States, 35249
Actively Recruiting
Research Team
Q
Quenteeria Mooney
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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