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Trial Title:
Improved Successful Retrieval Rate of HydroMARK Plus Breast Biopsy Site Marker in Comparison to HydroMARK as Well as Improved Surgeon Satisfaction
NCT ID:
NCT06294574
Condition:
Breast Neoplasm
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
HydroMARK Plus Clip
Description:
Each patient will undergo a breast localization procedure, and a HydroMARK plus clip will
be placed.
Arm group label:
Hydromark plus clip placement
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
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Kirklin Clinic
Address:
City:
Birmingham
Zip:
35249
Country:
United States
Contact:
Last name:
Quenteeria Mooney
Phone:
205-996-1082
Email:
qmooney@uabmc.edu
Investigator:
Last name:
Ceren Yalniz, MD
Email:
Principal Investigator
Start date:
December 2024
Completion date:
December 2026
Lead sponsor:
Agency:
University of Alabama at Birmingham
Agency class:
Other
Collaborator:
Agency:
Mammotome
Agency class:
Other
Source:
University of Alabama at Birmingham
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06294574
