NCT05945186

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

July 14, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

July 6, 2023

Last Update Submit

July 13, 2023

Conditions

Hemodynamics

Keywords

HemodynamicsBlood Flow

Outcome Measures

Primary Outcomes (2)

  • Blood Velocity

    Blood Velocity (Baseline, Peak) will be assessed via ultrasound in the popliteal and femoral veins.

    baseline, +10 minutes

  • Time Average Mean Velocity

    Time Average Mean Velocity (Baseline, Augmented) will be assessed via ultrasound in the popliteal and femoral veins.

    baseline, +10 minutes

Secondary Outcomes (1)

  • Total Volume Flow

    baseline, +10 minutes

Study Arms (1)

Single Arm

EXPERIMENTAL

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.

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

Interventions

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

External intermittent pneumatic compression (IPC) systems are applied to subject legs and comprise of a controller, associated tubing set and single patient use disposable leg sleeves. The disposable sleeves are latex free and contain air bladder(s) that are inflated by the controller to provide compression to the legs/feet. These devices are designed to increase venous blood flow in at risk patients in order to help prevent Venous ThromboEmbolism (VTE), including Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).

Single Arm

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jobst Vascular Institute

Toledo, Ohio, 43606, United States

RECRUITING

Study Officials

  • Fedor Lurie

    Jobst Vascular Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria Colasanto

CONTACT

508-618-3574victoria.colasanto@cardinalhealth.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2023

First Posted

July 14, 2023

Study Start

August 1, 2023

Primary Completion

October 1, 2023

Study Completion

November 1, 2023

Last Updated

July 14, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)