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

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.

Study Overview

• Status: Recruiting
• Conditions: Hemodynamics
• Intervention / Treatment: Device: Intermittent Pneumatic Compression (IPC)(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.

• Study Type: Interventional
• Enrollment (Estimated): 19
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Victoria Colasanto; Phone Number: 508-618-3574; Email: victoria.colasanto@cardinalhealth.com

Study Locations

• United States
  • Ohio
    • Toledo, Ohio, United States, 43606
      • Recruiting
      • Jobst Vascular Institute
      • Contact: study coordinator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single Arm; Baseline blood flow (hemodynamic) measurements will be obtained via ultrasound for all enrolled subjects. Following baseline measurements, compression will be applied and blood flow (hemodynamic) measurements will be repeated via ultrasound.

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Velocity	Blood Velocity (Baseline, Peak) will be assessed via ultrasound in the popliteal and femoral veins.	baseline, +10 minutes
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Volume Flow	Total Volume Flow (Baseline, Augmented) will be assessed via ultrasound in the popliteal and femoral veins.	baseline, +10 minutes

Collaborators and Investigators

• Sponsor: Cardinal Health
• Investigators: Principal Investigator: Fedor Lurie, Jobst Vascular Institute

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): November 1, 2023

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 14, 2023

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Hemodynamics; Blood Flow
• Other Study ID Numbers: 450.30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No