Safety and Feasibility of the ElastiMed's SACS

Study Overview
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Brief Summary
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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 .

Official Title
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Safety and Feasibility of the ElastiMed's SACS - Smart Active Compression Stocking

Conditions
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Compression; Vein

Intervention / Treatment
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* Device: ElastiMed's SACS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 18<x<70 Years Written informed consent has been sign by subject With two healthy limbs - Normal blood flow according to leg deep vein Duplex test Exclusion Criteria: Positive pregnancy test Breastfeeding woman BMI 18.5 > X or X>25 Suffering from edema Atrial fibrillation DVT Ulcers or cellulitis in regions covered by the compression device Active phlebitis Muscular disorders, or compartment syndrome Heavy smoker >10 cigarettes a day Subjects with altered mental status/inability to provide informed consent Hematological disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ElastiMed's SACS<br>Healthy Subjects which the Elastimed's SACS will be tried on | Device: ElastiMed's SACS<br>* A wearable medical device that improve circulation using smart materials<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 60 min |