Evaluating the Hemodynamic Performance of the VenAir Sequential Compression System
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-64
SponsorWellell Inc. Taiwan
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Healthy adults
Aged 20-64 years
Leg circumference within the size range of the SCD700 and VenAir garments
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
VenAir
DeviceVenAir 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
DeviceSCD700 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.
Treatment groups
105 Participants
are divided into 2 treatment groupsGroup A: VenAirExperimental treatment 1 intervention
Group B: SCD700Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Peak Velocity of Blood Flow Increasement
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.
Time frame
During and immediately after device applicationSponsors and contacts
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Source ClinicalTrials.gov