RecruitingNot ApplicableNCT07287007

Evaluating the Hemodynamic Performance of the VenAir Sequential Compression System


Sponsor

Wellell Inc. Taiwan

Enrollment

105 participants

Start Date

Oct 6, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 20 YearsMax Age: 64 Years

Inclusion Criteria3

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

Exclusion Criteria10

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEVenAir

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.

DEVICESCD700

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.


Locations(1)

Wellell Inc.

New Taipei City, Taiwan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07287007