Safety and Efficacy of the ElastiMed's SACS 2.0 - Smart Active Compression Stocking for the Treatment of Venous Edema

Study Overview
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Brief Summary
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Device Efficacy: The primary efficacy assessment will be defined as successful if the edema volume will be reduced over time after using the SACS 2.0 device. Treatment and edema evaluation will be performed in comparison to a standard compression bandage. The treatment will be performed for several hours during the subject's daily rest time. The Measurements will be performed daily before treatment initiation and without the device on the leg (baseline) (T0); and after four hours of device operation. The edema volume will be measured by a calf circumference measurement.

Official Title
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Safety and Efficacy of the ElastiMed's SACS 2.0 - Smart Active Compression Stocking

Conditions
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Edema Leg, Compression; Vein

Intervention / Treatment
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* Device: ElastiMed's SACS 2.0


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be between 18 to 80 years old Venous edema patients diagnosed by an indent in the skin following finger pressure. Venous edema in both calves Temporarily or permanently wheelchair users which are expected to remain so according to the investigator's discretion Subjects able to provide a written informed consent No existence of DVT according to leg deep vein Duplex test Exclusion Criteria as reported by patients: : Positive pregnancy test Breastfeeding woman moderate or severe Congestive heart failure Cellulitis of tissues of the lower limb. Infectious Dermatitis of the lower limb Acute or within 6 weeks of a deep vein thrombosis (DVT). Postphlebetic patients Known hypersensitivity to any component of the device Subjects unable to provide informed consent Active cancer at the root of the limb or in the adjacent quadrant Any limitation of renal function- according to the investigator's discretion Any limitation of liver function - according to the investigator's discretion Subject who cannot commit to a month of intensive standard therapy Wound or other skin condition that, according to the investigator's discretion, might be aggravated by the garment Currently participating in another clinical trial or have completed their participation in a clinical trial within 30 days of screening Other physical and/or mental conditions that, according to the investigator's discretion, prevent the subject from participating in the trial and completing its assessments Cardiac or cerebral pacemaker or stimulator Patients after orthopedic / vascular injury in the lower extremities

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Temporarily or permanently wheelchair users which suffer from Venous Edema<br>Temporarily or permanently wheelchair users which suffer from Venous Edema | Device: ElastiMed's SACS 2.0<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 Endpoint | Accumulative rate of device related SAEs throughout the trial duration. | Device operation hours during 10 business days | 
| Efficacy Endpoint | To demonstrate the efficacy by following the edema volume reduction after device application, in venous edema subjects, by measuring the calf circumference | Device operation hours during 10 business days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Efficacy Endpoint | To demonstrate the efficacy by changing the edema volume after using the SACS 2.0 device at least as much as after using a compression bandage | Device operation hours during 10 business days |