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

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Breast Neoplasm

Treatments: Device: HydroMARK Plus Clip

Study type: Interventional

Funder types: Other

Identifiers

NCT06294574

000544990 (Other Grant/Funding Number)

300011943

Details and patient eligibility

About

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.

Full 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

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Hydromark plus clip placement

Experimental group

Description:

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.

Treatment:

Device: HydroMARK Plus Clip