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

Edema Leg Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04837560
Study type Interventional
Source ElastiMed ltd
Contact Vered Shuster, PhD
Phone +972-54- 6819828
Email vered@elastimed.com
Status Recruiting
Phase Phase 1
Start date April 2021
Completion date December 2021
View Details
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