Breast Neoplasm
Conditions
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
Interventions
DEVICEHydroMARK Plus Clip
Each patient will undergo a breast localization procedure, and a HydroMARK plus clip will be placed.
Sponsors
Mammotome
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactQuenteeria Mooney
Outcome results
None listed