The main objective of this study is to demonstrate the safety and the feasibility of this device, and its ability to increase venous blood flow Primary safety Endpoint: To demonstrate the safety of the device- no serious adverse effect Primary feasibility Endpoint: Increase the blood flow velocity The blood flow will be detected by a Duplex Ultrasonography test at the popliteal vein and the femoral vein. The volunteers will rest at controlled environment room . Measurements will be performed after 30 min of rest without the device on the leg (baseline) and after 30 min of device activity .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
11
A wearable medical device that improve circulation using smart materials
Vascular Surgery Department, HILLEL YAFFE Medical Center,
Hadera, Israel
Safety measured by the number of subjects with serious adverse events
The safety analysis set will contain of all subjects who were enrolled into the study. Individual listings of adverse events including type of device, adverse events (reported term), seriousness, duration, relationship to the study device, severity and the adverse events outcome will be provided
Time frame: 60 min
Device feasibility measured by an increase in blood flow velocity
The primary feasibility assessment will be based on the ability of the device to increase the blood flow velocity at the popliteal vein. The blood flow will be detected by a Duplex Ultrasonography test at the popliteal vein. Two Measurements will be performed, the first will be after 30 minutes of rest without the device on the leg (baseline) (T0) and the second will be after 30 min of device activity
Time frame: 60 min
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