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

Venous Thromboses Clinical Trial

Official title:

A Crossover Study of the Hemodynamic Effect of the OsciPulse Device Compared to Reference Therapies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05087108
• Other study ID #: OSC-VTE-002
• Secondary ID: R44HL145860
• Status: Completed
• Phase: Early Phase 1
• Start date: March 17, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: March 2023
• Source: OsciFlex LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Enrolled healthy subjects will undergo and initial vascular ultrasound imaging procedure to locate a deep venous valve in either the sapheno-femoral junction or femoral trifurcation sites. Once the imaging valve is identified the baseline level of venous flow will be collected in 30 s video clips of 2D color Doppler videos and spectral Doppler. Next, either the OsciPulse device, or one of the two reference therapy devices, will be applied by study personnel according to the device's specific instructions. The subject will wear the device during the capture of 1 spectral Doppler clip and three 30 s 2D color Doppler ultrasound clips on both the left and right leg. Next, the remaining two devices will be applied based on instructions, and vascular ultrasound clips captured for each. Completion of this visit protocol will be the end of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Thrombosis
• Varicose Ulcer
• Venous Stasis
• Venous Thromboses
• Venous Thrombosis

Intervention

Device:
• OsciPulse system
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.
• Reference Therapy 1
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.
• Refence Therapy 2
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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
OsciFlex LLC	National Heart, Lung, and Blood Institute (NHLBI), University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Deep vein centerline flow	The velocity of venous flow measured by spectral Doppler ultrasound in the deep femoral vein.	Visit 1 - 60 minutes
Primary	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