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

Purpose

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.

Condition

  • Breast Neoplasm

Eligibility

Eligible Ages
Between 18 Years and 90 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

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

Recruiting Locations

The Kirklin Clinic
Birmingham 4049979, Alabama 4829764 35249
Contact:
Quenteeria Mooney
205-996-1082
qmooney@uabmc.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Quenteeria Mooney
205-996-1082
qmooney@uabmc.edu

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