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

Early Phase 1

Completed

• Conditions: Venous Stasis; Venous Thromboses
• Interventions: Device: OsciPulse system; Device: Reference Therapy 1; Device: Refence Therapy 2

• Registration Number: NCT05087108
• Lead Sponsor: OsciFlex LLC

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-09-28
• Study First Submitted QC: 2021-10-08
• Study First Posted: 2021-10-21
• Study Start: 2022-03-17
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study arm	Refence Therapy 2	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.
Study arm	OsciPulse system	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.
Study arm	Reference Therapy 1	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.

Primary Outcome Measures

Name	Time	Method
Venous valve sinus rouleaux	Visit 1 - 60 minutes	The degree of red blood cell rouleaux in the sinus of venous valves will be measured using B-mode ultrasound.
Venous valve sinus forward flow volume index	Visit 1 - 60 minutes	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.
Venous valve sinus reversing flow volume index	Visit 1 - 60 minutes	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.
Deep vein centerline flow	Visit 1 - 60 minutes	The velocity of venous flow measured by spectral Doppler ultrasound in the deep femoral vein.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States