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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temporarily or permanently wheelchair users which suffer from Venous Edema | Experimental | Temporarily or permanently wheelchair users which suffer from Venous Edema |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ElastiMed's SACS 2.0 | Device | A wearable medical device that improve circulation using smart materials |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria as reported by patients: :
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vered Shuster, PhD | Contact | +972-54- 6819828 | vered@elastimed.com | |
| Omer Zelka | Contact | +972-52- 6339131 | omer@elastimed.com |
| Name | Affiliation | Role |
|---|---|---|
| Israel Dudkiewicz, Prof. | Sheba Medical Center at Tel HaShomer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Medical Center at Tel HaShomer | Recruiting | Ramat Gan | 52621 | Israel |
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