Design Validation Hemodynamic Study of New Kendall SCD SmartFlow Compression System

Cardinal Health

Status: Enrolling

Conditions: Hemodynamics

Treatments: Device: Intermittent Pneumatic Compression (IPC)(Kendall SCD SmartFlow™ compression system with Cardinal Health Element compression sleeves)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05945186

450.30

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Single Arm

Experimental group

Description:

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.

Treatment:

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