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

NCT ID: NCT05087108

Last Updated: 2023-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-17
• Study Completion Date: 2022-06-30

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.

Conditions

Venous Thromboses; Venous Stasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Study arm

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.

Group Type: EXPERIMENTAL

OsciPulse system

Intervention Type: 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.

Reference Therapy 1

Intervention Type: 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.

Refence Therapy 2

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Venaflow Elite Vascular System; Kendall 700 Series SCD

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

OsciFlex LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Welsh, PhD

Role: STUDY_DIRECTOR

OsciFlex LLC

Chandra Sehgal, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

R44HL145860

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OSC-VTE-002

Identifier Type: -

Identifier Source: org_study_id