HydroMARK Plus versus HydroMARK: comparing biopsy site marker retrieval and surgeon satisfaction
Official title: Improved Successful Retrieval Rate of HydroMARK Plus Breast Biopsy Site Marker in Comparison to HydroMARK as Well as Improved Surgeon Satisfaction
Run by University of Alabama at Birmingham · NCT06294574 · Data updated 2026-11-12
This trial will test whether the HydroMARK Plus breast biopsy marker is retrieved more successfully than the current HydroMARK and whether surgeons are more satisfied with its removal for patients having biopsy clips removed during surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | Women only |
| Enrollment | 150 (estimated) |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Status | Recruiting |
| Started | August 5, 2025 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | September 25, 2026 |
| Trial ID | NCT06294574 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 to 90 who already have a breast biopsy clip and are scheduled for surgery with SCOUT localization are ideal candidates.
✕Probably not a fit
Patients who will not have surgery, are under 18 or over 90, are inmates, or cannot consent in English are not eligible and would not be expected to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares the retrieval success of the newer HydroMARK Plus biopsy site marker to the existing HydroMARK in patients who already have biopsy clips and are scheduled for surgical removal using SCOUT localization. The primary outcome is the rate of successful marker retrieval at surgery, and the secondary outcome is surgeon satisfaction with retrieval. Eligible adult patients (18–90 years) with biopsy clips scheduled for SCOUT-localized surgery are enrolled at The Kirklin Clinic, with exclusions for inmates and non-English speakers. The University of Alabama at Birmingham is the lead sponsor and the device is provided in collaboration with Mammotome, with procedures and data collection performed at the single study site.
Why it matters
Potential benefit: If successful, HydroMARK Plus could increase the likelihood of finding and removing biopsy markers at surgery, potentially reducing repeat procedures and improving operating-room workflow.
How similar studies have gone: Prior device-comparison studies have shown modest improvements in marker retrieval with design changes, but HydroMARK Plus represents a relatively incremental device innovation with limited published data so far.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with biopsy clips scheduled for surgery with SCOUT localization Exclusion Criteria: * Patients who didn't have surgery, patients younger than 18 years old * Patients older than 90 years old * Inmates * Non-English speakers
Where it's running
-
The Kirklin Clinic
Birmingham, Alabama, United States Recruiting
Study contacts
- Principal investigator: Ceren Yalniz, MD — University of Alabama at Birmingham
- Study coordinator: Quenteeria Mooney
- Email: qmooney@uabmc.edu
- Phone: 205-996-1082
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.