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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
A wearable medical device that improve circulation using smart materials
Sheba Medical Center at Tel HaShomer
Ramat Gan, Israel
RECRUITINGSafety Endpoint
Accumulative rate of device related SAEs throughout the trial duration.
Time frame: 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
Time frame: Device operation hours during 10 business days
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
Time frame: Device operation hours during 10 business days
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