Design Validation Hemodynamic Study of New Kendall SCD SmartFlow Compression System

NCT ID: NCT05945186

Last Updated: 2023-07-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2023-11-30

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.

Conditions

Hemodynamics

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Single Arm

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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).

Interventions

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

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).

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cardinal Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fedor Lurie

Role: PRINCIPAL_INVESTIGATOR

Jobst Vascular Institute

Locations

Jobst Vascular Institute

Toledo, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Victoria Colasanto

Role: CONTACT

victoria.colasanto@cardinalhealth.com

508-618-3574

Facility Contacts

Study Coordinator

Role: primary

Other Identifiers

450.30

Identifier Type: -

Identifier Source: org_study_id