Evaluating the Hemodynamic Performance of the VenAir Sequential Compression System

Wellell Inc. Taiwan

Status: Enrolling

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

Treatments: Device: VenAir; Device: SCD700

Study type: Interventional

Funder types: Industry

Identifiers

NCT07287007

EC1140707-F

Details and patient eligibility

About

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.

Enrollment: 105 estimated patients

Sex: All

Ages: 20 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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105 participants in 2 patient groups

VenAir

Experimental group

Description:

The VenAir and its garments (thigh, calf, foot) will be tested in a randomized testing order.

Treatment:

Device: VenAir

SCD700

Active Comparator group

Description:

The SCD700 and its garments (thigh, calf, foot) will be tested in a randomized testing order.

Treatment:

Device: SCD700