Design Validation Hemodynamic Study of New Kendall SCD SmartFlow Compression System

Description

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.

Conditions

Hemodynamics

Study Overview

Study Details

Study overview

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.

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

Design Validation Hemodynamic Study of New Kendall SCD SmartFlow Compression System

Condition
Hemodynamics
Intervention / Treatment

-

Contacts and Locations

Toledo

Jobst Vascular Institute, Toledo, Ohio, United States, 43606

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to 89 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Cardinal Health,

Fedor Lurie, PRINCIPAL_INVESTIGATOR, Jobst Vascular Institute

Study Record Dates

2023-11