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NCT06294574 Clinical Trial

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

Breast Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06294574
Other study ID # 300011943
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 2024
Est. completion date December 2026

Study information
Verified date March 2024
Source University of Alabama at Birmingham
Contact Quenteeria Mooney
Phone 205-996-1082
Email qmooney@uabmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 150
Est. completion date December 2026
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 90 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States The Kirklin Clinic Birmingham Alabama

Sponsors (2)
Lead Sponsor Collaborator
University of Alabama at Birmingham Mammotome

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Retrieval rate of the HydroMARK Plus clip. 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. Date of HydroMARK Plus Clip placement to 1 week plus or minus 5 days
Secondary Level of satisfaction of the surgeon with the retrieval of the HydroMARK Plus clip. Surgeon satisfaction will be evaluated using a Likert scale survey. Date of retrieval surgery to 1 week.
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