RECRUITING

Design Validation Hemodynamic Study of New Kendall SCD SmartFlow Compression System

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-08

Study Completion:2023-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05945186

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.

Ages Eligible for Study:18 Years to 89 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Victoria Colasanto

CONTACT

508-618-3574

victoria.colasanto@cardinalhealth.com

Principal Investigator

Fedor Lurie

PRINCIPAL_INVESTIGATOR

Jobst Vascular Institute

Study Locations (Sites)

Jobst Vascular Institute

Toledo, Ohio, 43606

United States

Collaborators and Investigators

Sponsor: Cardinal Health

Fedor Lurie, PRINCIPAL_INVESTIGATOR, Jobst Vascular Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08

Study Completion Date2023-11

Study Record Updates

Study Start Date2023-08

Study Completion Date2023-11

Terms related to this study

Keywords Provided by Researchers

Hemodynamics
Blood Flow

Additional Relevant MeSH Terms

Hemodynamics