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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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ElastiMed's SACS | Experimental | Healthy Subjects which the Elastimed's SACS will be tried on |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ElastiMed's SACS | Device | A wearable medical device that improve circulation using smart materials |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vered Shuster, PhD | ElastiMed ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vascular Surgery Department, HILLEL YAFFE Medical Center, | Hadera | 38100 | Israel |
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