Back to search results

HydroMARK Plus Breast Biopsy Site Marker Study

This study is testing a new device called the HydroMARK Plus clip, which is used to mark the site of a breast biopsy. Researchers want to see how often this new clip can be successfully retrieved (removed) compared to the older HydroMARK clip. They also want to know how satisfied surgeons are with removing the HydroMARK Plus clip. You may be able to join if you are a woman between 18 and 90 years old who is scheduled for surgery to remove a biopsy clip using a SCOUT localization procedure. The main goal is to measure how often the HydroMARK Plus clip is successfully retrieved. The current recruitment status is unclear, and the study plans to enroll 150 participants.

Study design
This interventional study plans to enroll 150 women. It is designed to compare the retrieval success of the HydroMARK Plus clip.
What's involved
Each patient will undergo a breast localization procedure where a HydroMARK Plus clip will be placed.
Compensation
Not stated in the trial record.
Follow-up
The retrieval rate of the HydroMARK Plus clip will be measured from the date of placement to 1 week (plus or minus 5 days).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06294574

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

Recruiting
NAAges 18–90InterventionalDiagnostic
University of Alabama at Birmingham
~150 participants
Updated 2025-09-22 on ClinicalTrials.gov
What's tested:HydroMARK Plus Clip

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Retrieval rate of the HydroMARK Plus clip.
Measured over Date of HydroMARK Plus Clip placement to 1 week plus or minus 5 days

Conditions

Breast Neoplasm

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Alabama1

Study leadership

  • Ceren Yalniz, MD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham

Who to contact

Quenteeria Mooney
[email protected]
205-996-1082
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Patients with biopsy clips scheduled for surgery with SCOUT localization

Exclusion

Patients who didn't have surgery, patients younger than 18 years old
Patients older than 90 years old
Inmates
Non-English speakers

What this trial measures

  • Retrieval rate of the HydroMARK Plus clip.Date of HydroMARK Plus Clip placement to 1 week plus or minus 5 days

    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.