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NCT Number: NCT07287007

Evaluating the Hemodynamic Performance of the VenAir Sequential Compression System

The goal of this clinical trial is to learn an Intermittent Pneumatic Compression Device (IPCD), VenAir, effectiveness in healthy adults. The main questions this research aims to answer are:

1. The hemodynamic performance of VenAir paired with the thigh garments, calf garments, and foot garments is not inferior to that of SCD700 paired with the corresponding garments. 2. The hemodynamic performance of VenAir paired with the thigh garments, calf garments, and foot garments is not inferior to that of SCD700 paired with the thigh garment.

Researchers will compare VenAir and the SCD700 to see if the hemodynamic performance of VenAir is as well as or not worse than the SCD700.

Participants will lie down and rest for approximately 30 minutes to stabilize their heart rate. The researcher will then use ultrasound to measure the participant's blood flow while they wear different leg garments (one at a time) and also when no garment is worn.

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Key information

Conditions

No Condition, Healthy Individuals No Conditions, Aged 20-64

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adults
  • Aged 20-64 years
  • Leg circumference within the size range of the SCD700 and VenAir garments

Exclusion criteria

  • Cardiovascular-related diseases (mild atherosclerosis, other ischemic vascular diseases, congestive heart failure, etc.)
  • Previous suspicion of deep vein thrombosis, pulmonary embolism, or phlebitis
  • History of stroke
  • History of varicose vein surgery
  • Hypertension
  • Diabetes
  • Dermatitis, gangrene, or severe wounds
  • Massive edema of legs
  • Pregnancy
  • Pulmonary edema

Treatment and study plan

VenAir

Device

VenAir is an intermittent pneumatic compression (IPC) device intended to help prevent venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE). In this study, VenAir is applied to the participant's lower limb under standard operating settings, and hemodynamic performance is measured for comparison with SCD700.

SCD700

Device

SCD700 is a commercially available intermittent pneumatic compression (IPC) device used to prevent venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE). In this study, SCD700 is applied to the participant's lower limb under standard operating settings, and hemodynamic performance is measured to compare with VenAir.

Primary outcomes

  1. Peak Velocity of Blood Flow Increasement

    Time frame: During and immediately after device application

    The peak velocity increasement is measured to understand the degree of change in peak blood flow velocity with and without using the IPC device. Baseline peak velocity is calculated by averaging the two highest peaks over a 16-second period without the device. Intervention peak velocity is obtained by averaging the peak velocities over four compression cycles while wearing the IPC device.

Study contacts

Contact information is provided by the study sponsor or research team.

Cheng Yung Chang

CONTACT

[email protected]

+886 2-2268-5568 ext. 2804

Sponsors and collaborators

Lead sponsor

Wellell Inc. Taiwan

Industry

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2025
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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