Clinical Trial of the WC360 SiteSeal Adjunctive Compression Device Following Interventional Endovascular Procedures
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
Summary
- Conditions
- Bleeding
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 19 years and 90 years
- Gender
- Both males and females
Description
The study design is a single arm with 90 patients. The primary endpoints measure the risk for common femoral nerve damage and common femoral artery laceration from the blind placement of a Z-stitch in the soft tissue above the femoral bundle. The sample size is 90 patients. The project objective is ...
The study design is a single arm with 90 patients. The primary endpoints measure the risk for common femoral nerve damage and common femoral artery laceration from the blind placement of a Z-stitch in the soft tissue above the femoral bundle. The sample size is 90 patients. The project objective is to demonstrate the safety of the device.
Tracking Information
- NCT #
- NCT03234894
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Elias Kassab, MD MOVI Principal Investigator: Matthew Earnest, MD University of Kansas Medical Center
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