NCT05087108

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: OsciFlex LLC · Industry
• Sex: All
• Age: 40 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• Venous Thromboses
• Venous Stasis

Interventions

Type	Name	Description
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.
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2022-03-17
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2021-10-21
• Last updated: 2023-08-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study