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Recruiting NCT06294574

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

No phase Interventional Breast Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HydroMARK Plus Clip.
Who it may be relevant to
Registry conditions: Breast Neoplasm. Basic parameters: 18 years — 90 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

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

Interventions

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

Primary outcome measures

  • Retrieval rate of the HydroMARK Plus clip. [Time frame: Date of HydroMARK Plus Clip placement to 1 week plus or minus 5 days]
Secondary outcome measures (1)
  • Level of satisfaction of the surgeon with the retrieval of the HydroMARK Plus clip. [Time frame: Date of retrieval surgery to 1 week.]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • The Kirklin Clinic — Birmingham

Identifiers

NCT: NCT06294574 · 300011943 · 000544990

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗