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NCT Number: NCT06294574

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

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.

Recruiting

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Key information

Conditions

Breast Neoplasm Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Kirklin Clinic

Birmingham, Alabama, 35249, United States

Location status: Recruiting

Location contact

Ceren Yalniz, MD

PRINCIPAL_INVESTIGATOR

Quenteeria Mooney

CONTACT

[email protected]

205-996-1082

About this study

Study objectives

Primary objective

Assess the successful retrieval rates of the HydroMARK Plus clip

Secondary objective

Determine the level of satisfaction of the surgeon with the retrieval of the HydroMARK Plus clip

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HydroMARK Plus Clip

Device

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

Primary outcomes

  1. Retrieval rate of the HydroMARK Plus clip.

    Time frame: 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.

Secondary outcomes

  1. Level of satisfaction of the surgeon with the retrieval of the HydroMARK Plus clip.

    Time frame: Date of retrieval surgery to 1 week.

    Surgeon satisfaction will be evaluated using a Likert scale survey.

Study contacts

Contact information is provided by the study sponsor or research team.

Quenteeria Mooney

CONTACT

[email protected]

205-996-1082

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Mammotome

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 5, 2024
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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