NCT05945186

Design Validation Hemodynamic Study of New Kendall SCD SmartFlow Compression System

Design Validation Hemodynamic Study of New Kendall SCD SmartFlow Compression System With Cardinal Health Element Compression Sleeves

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (estimated)
• Sponsor: Cardinal Health · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

Summary

This study is being conducted to evaluate the hemodynamic performance (i.e. flow of blood) in the legs using the new Kendall SCD SmartFlow™ compression system with Cardinal Health Element compression sleeves.

Detailed description

This study is being conducted to evaluate hemodynamic performance using the new Kendall SCD SmartFlow™ compression system with Cardinal Health Element compression sleeves. The study is intended to confirm the system's ability to increase venous blood flow over baseline as measured by blood velocity, time average mean velocity and total volume flow, in both the femoral and popliteal veins.

Conditions

• Hemodynamics

Interventions

Type	Name	Description
DEVICE	Intermittent Pneumatic Compression (IPC)(Kendall SCD SmartFlow™ compression system with Cardinal Health Element compression sleeves)	External intermittent pneumatic compression (IPC) systems are applied to subject legs and comprise of a controller, associated tubing set and single patient use disposable leg sleeves. The disposable sleeves are latex free and contain air bladder(s) that are inflated by the controller to provide compression to the legs/feet. These devices are designed to increase venous blood flow in at risk patients in order to help prevent Venous ThromboEmbolism (VTE), including Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).

Timeline

• Start date: 2023-08-01
• Primary completion: 2023-10-01
• Completion: 2023-11-01
• First posted: 2023-07-14
• Last updated: 2023-07-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study