Clinical trial NCT05945186: Design Validation Hemodynamic Study of New Kendall SCD SmartFlow Compression System
Official title: Design Validation Hemodynamic Study of New Kendall SCD SmartFlow Compression System With Cardinal Health Element Compression Sleeves
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemodynamics
Keywords: Hemodynamics
Blood Flow
Lead sponsor: Cardinal Health
Sponsor class: INDUSTRY
First posted: 2023-07-14
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood Velocity
timeFrame: baseline, +10 minutes
measure: Time Average Mean Velocity
timeFrame: baseline, +10 minutes
Secondary outcomes:
measure: Total Volume Flow
timeFrame: baseline, +10 minutes
Other outcomes:
Locations:
city: Toledo
country: United States
facility: Jobst Vascular Institute
state: Ohio
Study officials:
affiliation: Jobst Vascular Institute
name: Fedor Lurie
role: PRINCIPAL_INVESTIGATOR
References: