Design Validation Hemodynamic Study of New Kendall SCD SmartFlow Compression System

Hemodynamics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05945186
• Other study ID #: 450.30
• Status: Recruiting
• Phase: N/A
• Start date: August 2023
• Est. completion date: November 2023

Study information

• Verified date: July 2023
• Source: Cardinal Health
• Contact: Victoria Colasanto
• Phone: 508-618-3574
• Email: victoria.colasanto[@]cardinalhealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 19
• Est. completion date: November 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Subject must be =18 years and = 89 years of age.

• Subject must be able to speak and read English.

• Subject must have both legs fully intact (cannot be an amputee) with normal function.

• Subject must be able to commit to the full study duration (approximately 1-2 hours of uninterrupted time).

• Subject legs must fit into the provided knee length compression sleeves (<32").

• Subject must give written informed consent.

Exclusion Criteria:

• Subject is currently pregnant or breastfeeding.

• Subject has a positive COVID history within the previous 6 months.

• Subject presents with

• - local leg condition with which the sleeves would interfere such as dermatitis, vein ligation (immediate post-operative), gangrene, recent skin graft, or any other open wound

• - arteriosclerosis or other ischemic vascular diseases as indicated by absence of pedal pulses and/or history of intermittent claudication with positive pain response

• - edema of legs or pulmonary edema from congestive heart failure

• - deformity of the leg

• - current Deep Vein Thrombosis as identified during baseline clinical screening

• - recent or old Deep Vein Thrombosis as identified during baseline clinical screening

• - reflux in the superficial or deep veins

• - history of DVT/PE

• - known May-Thurner Syndrome

• Subject who, in the opinion of the investigator, is not an appropriate candidate for the study

Related Conditions & MeSH terms

• Hemodynamics

Intervention

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).

Locations

Country	Name	City	State
United States	Jobst Vascular Institute	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Cardinal Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Velocity	Blood Velocity (Baseline, Peak) will be assessed via ultrasound in the popliteal and femoral veins.	baseline, +10 minutes
Primary	Time Average Mean Velocity	Time Average Mean Velocity (Baseline, Augmented) will be assessed via ultrasound in the popliteal and femoral veins.	baseline, +10 minutes
Secondary	Total Volume Flow	Total Volume Flow (Baseline, Augmented) will be assessed via ultrasound in the popliteal and femoral veins.	baseline, +10 minutes