Improved Successful Retrieval Rate of HydroMARK Plus Breast Biopsy Site Marker in Comparison to HydroMARK as Well as Improved Surgeon Satisfaction
Purpose
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.
Condition
- Breast Neoplasm
Eligibility
- Eligible Ages
- Between 18 Years and 90 Years
- Eligible Sex
- Female
- Accepts 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Hydromark plus clip placement |
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. |
|
Recruiting Locations
The Kirklin Clinic
Birmingham 4049979, Alabama 4829764 35249
Birmingham 4049979, Alabama 4829764 35249
More Details
- Status
- Recruiting
- Sponsor
- University of Alabama at Birmingham
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