Trials / Recruiting
RecruitingNCT06294574
Improved Successful Retrieval Rate of HydroMARK Plus Breast Biopsy Site Marker in Comparison to HydroMARK as Well as Improved Surgeon Satisfaction
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- University of Alabama at Birmingham · Academic / Other
- Sex
- Female
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | HydroMARK Plus Clip | Each patient will undergo a breast localization procedure, and a HydroMARK plus clip will be placed. |
Timeline
- Start date
- 2025-08-05
- Primary completion
- 2027-12-01
- Completion
- 2027-12-01
- First posted
- 2024-03-05
- Last updated
- 2025-09-22
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06294574. Inclusion in this directory is not an endorsement.