Compression; Vein
Conditions
Brief summary
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 .
Interventions
DEVICEElastiMed's SACS
A wearable medical device that improve circulation using smart materials
Sponsors
ElastiMed ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Adults 18\<x\<70 Years 2. Written informed consent has been sign by subject 3. With two healthy limbs - Normal blood flow according to leg deep vein Duplex test
Exclusion criteria
1. Positive pregnancy test 2. Breastfeeding woman 3. BMI 18.5 \> X or X\>25 4. Suffering from edema 5. Atrial fibrillation 6. DVT 7. Ulcers or cellulitis in regions covered by the compression device 8. Active phlebitis 9. Muscular disorders, or compartment syndrome 10. Heavy smoker \>10 cigarettes a day 11. Subjects with altered mental status/inability to provide informed consent 12. Hematological disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety measured by the number of subjects with serious adverse events | 60 min | 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 |
| Device feasibility measured by an increase in blood flow velocity | 60 min | 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 |
Countries
Israel
Outcome results
None listed