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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
150
Each patient will undergo a breast localization procedure, and a HydroMARK plus clip will be placed.
The Kirklin Clinic
Birmingham, Alabama, United States
RECRUITINGRetrieval 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.
Time frame: Date of HydroMARK Plus Clip placement to 1 week plus or minus 5 days
Level of satisfaction of the surgeon with the retrieval of the HydroMARK Plus clip.
Surgeon satisfaction will be evaluated using a Likert scale survey.
Time frame: Date of retrieval surgery to 1 week.
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