Evaluation of the OsciPulse Rapid Cycling Compression Device Effects on Venous Blood Flow

NCT05087108 | Completed Early Phase 1 FDA Device

• 2 other identifiers: OSC-VTE-002R44HL145860
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effects on venous blood flow of the investigational device, OsciPulse system, which is an external intermittent limb compression device. The study will enroll healthy human subjects who will have their deep venous blood flow measured by vascular ultrasound during immobility, use of the OsciPulse system, and use of two reference vascular compression devices. Our hypothesis is that the OsciPulse system will create distinct patterns of venous flow, specifically at the site of venous valves, in comparison to the reference compression devices.

Conditions

Venous Thromboses; Venous Stasis

Keywords

Venous compression; Intermittent pneumatic compression

Outcome Measures

Primary Outcomes (4)

• Venous valve sinus forward flow volume index

  The volume flow index (mL/mL) will be measured for flow in the valve sinus region that is moving back towards the heart (forward flow). The venous flow at a valve will be measured using 2D color Doppler ultrasound, and flow volume index calculated from the resulting video clips.

  Visit 1 - 60 minutes

• Venous valve sinus reversing flow volume index

  The volume flow index (mL/mL) will be measured for flow in the valve sinus region that is moving away from the heart (reversing flow). The venous flow at a valve will be measured using 2D color Doppler ultrasound, and flow volume index calculated from the resulting video clips.

  Visit 1 - 60 minutes

• Deep vein centerline flow

  The velocity of venous flow measured by spectral Doppler ultrasound in the deep femoral vein.

  Visit 1 - 60 minutes

• Venous valve sinus rouleaux

  The degree of red blood cell rouleaux in the sinus of venous valves will be measured using B-mode ultrasound.

  Visit 1 - 60 minutes

Study Arms (1)

Study arm

EXPERIMENTAL

In this single arm study all enrolled subjects will the intervention by the investigational device, and both reference devices. Ultrasound will be used to measure the blood flow in the subject during the use of all three devices.

Device: OsciPulse system; Device: Reference Therapy 1; Device: Refence Therapy 2

Interventions

OsciPulse system DEVICE

The OsciPulse system is an intermittent pneumatic limb compression system. The OsciPulse sleeves that are applied to the top portion of the user's calves and are periodically inflated with rapid bursts of compressed air to create frequent pulses of venous return.

Study arm

Reference Therapy 1 DEVICE

The Venaflow Elite is a sequential compression device that uses compressed air to inflate sleeves worn on the calf of the user to stimulate venous return. The Venaflow system sleeves cover the entire calf region of the user and contain two bladders that are inflated sequentially to induce venous return.

Also known as: Venaflow Elite Vascular System

Study arm

Refence Therapy 2 DEVICE

The Kendall SCD device is a sequential compression device that uses compressed air to inflate sleeves worn on the calf of the user to stimulate venous return. The Kendall SCD sleeves cover the entire calf region of the user and contain three bladders that are inflated sequentially to induce venous return.

Also known as: Kendall 700 Series SCD

Study arm

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult age ≥40 years old
• Generally healthy.
• No history of diagnosed vascular disease including: DVT, PE, VTE, peripheral vascular disease, post-phlebitic syndrome, or chronic venous insufficiency.
• Mentally alert and understand English proficiently.
• Able to give informed consent.

You may not qualify if:

• Skin breaks, abrasion, or irritation in the area of the limb in contact with the OsciPulse device or reference therapies.
• Severe peripheral artery or venous disease.

Sponsors & Collaborators

• OsciFlex LLC: lead
• University of Pennsylvania: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19146, United States

Location

MeSH Terms

Conditions

Venous Thrombosis; Varicose Ulcer

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Varicose Veins; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• John Welsh, PhD

  OsciFlex LLC

  STUDY DIRECTOR

• Chandra Sehgal, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 21, 2021
• Study Start: March 17, 2022
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: August 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The data will become available starting 6 months after publication of the study and will be available for 24 months upon request.
• Access Criteria: Qualifying IPD will be shared with specific requestors if they are at an academic or government institution and to be used for non-commercial research. Requests will be evaluated by OsciFlex LLC.

Locations

US (1)