MedTrace Logo

Design Validation Hemodynamic Study of New Kendall SCD SmartFlow Compression System

NCT05945186 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2023-07-14

No results posted yet for this study

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.

Conditions

  • Hemodynamics

Interventions

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).

Sponsors & Collaborators

  • Cardinal Health

    lead INDUSTRY

Principal Investigators

  • Fedor Lurie · Jobst Vascular Institute

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-31
Primary Completion
2023-10-31
Completion
2023-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05945186 on ClinicalTrials.gov