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

OsciFlex

Status and phase: Completed; Early Phase 1

Conditions: Venous Stasis; Venous Thromboses

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

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT05087108

R44HL145860 (U.S. NIH Grant/Contract)

OSC-VTE-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 40 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Study arm

Experimental group

Description:

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.

Treatment:

Device: Refence Therapy 2

Device: Reference Therapy 1

Device: OsciPulse system