Recruiting

HydroMARK vs. HydroMARK Plus

Sponsor:

University of Alabama at Birmingham

Code:

NCT06294574

Conditions

Breast Neoplasm

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

HydroMARK Plus Clip

Study Details

Brief summary:

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.

Conditions

Breast Neoplasm

Study ID

NCT06294574

Start date

Aug 5, 2025

Status verified date

Sep, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

HydroMARK Plus Clip

Each patient will undergo a breast localization procedure, and a HydroMARK plus clip will be placed.

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 and Locations

Central contacts

Quenteeria Mooney

205-996-1082qmooney@uabmc.edu

Locations

The Kirklin Clinic

Recruiting

Birmingham, Alabama, United States, 35249

Contacts

Quenteeria Mooney

205-996-1082qmooney@uabmc.edu

Principal Investigator:

Ceren Yalniz, MD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Sep 22, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2025-09-22.