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

Not Applicable

Not yet recruiting

• Conditions: Breast Neoplasm
• Interventions: Device: HydroMARK Plus Clip

• Registration Number: NCT06294574
• Lead Sponsor: University of Alabama at Birmingham

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.

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

Study Timeline

• Study First Submitted: 2024-02-28
• Study First Submitted QC: 2024-02-28
• Study First Posted: 2024-03-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-10
• Study Start: 2025-06
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hydromark plus clip placement	HydroMARK Plus Clip	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.

Primary Outcome Measures

Name	Time	Method
Retrieval rate of the HydroMARK Plus clip.	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 Outcome Measures

Name	Time	Method
Level of satisfaction of the surgeon with the retrieval of the HydroMARK Plus clip.	Date of retrieval surgery to 1 week.	Surgeon satisfaction will be evaluated using a Likert scale survey.

Trial Locations

Locations (1)

The Kirklin Clinic; 🇺🇸 Birmingham, Alabama, United States