Safety and Feasibility of the ElastiMed's SACS - Smart Active Compression Stocking
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- ElastiMed ltd
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Device feasibility measured by an increase in blood flow velocity
Study Overview
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 .
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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
Arms & Interventions
ElastiMed's SACS
Healthy Subjects which the Elastimed's SACS will be tried on
Intervention: ElastiMed's SACS (Device)
Outcomes
Primary Outcomes
Device feasibility measured by an increase in blood flow velocity
Time Frame: 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
Safety measured by the number of subjects with serious adverse events
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported