HydroMARK Plus versus HydroMARK: comparing biopsy site marker retrieval and surgeon satisfaction
Improved Successful Retrieval Rate of HydroMARK Plus Breast Biopsy Site Marker in Comparison to HydroMARK as Well as Improved Surgeon Satisfaction
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Female |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT06294574 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Birmingham, Alabama
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.