Design Validation Hemodynamic Study of New Kendall SCD SmartFlow Compression System

Not Applicable

Recruiting

• Conditions: Hemodynamics
• Interventions: Device: Intermittent Pneumatic Compression (IPC)(Kendall SCD SmartFlow™ compression system with Cardinal Health Element compression sleeves)

• Registration Number: NCT05945186
• Lead Sponsor: Cardinal Health

Brief 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.

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-06
• Study First Submitted QC: 2023-07-13
• Last Update Submitted: 2023-07-13
• Study First Posted: 2023-07-14
• Last Update Posted: 2023-07-14
• Study Start: 2023-08
• Primary Completion: 2023-10
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 19

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Intermittent Pneumatic Compression (IPC)(Kendall SCD SmartFlow™ compression system with Cardinal Health Element compression sleeves)	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.

Primary Outcome Measures

Name	Time	Method
Blood Velocity	baseline, +10 minutes	Blood Velocity (Baseline, Peak) will be assessed via ultrasound in the popliteal and femoral veins.
Time Average Mean Velocity	baseline, +10 minutes	Time Average Mean Velocity (Baseline, Augmented) will be assessed via ultrasound in the popliteal and femoral veins.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Jobst Vascular Institute; 🇺🇸 Toledo, Ohio, United States