NCT04837560

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: ElastiMed ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Edema Leg
• Compression; Vein

Interventions

Type	Name	Description
DEVICE	ElastiMed's SACS 2.0	A wearable medical device that improve circulation using smart materials

Timeline

• Start date: 2021-04-01
• Primary completion: 2021-08-01
• Completion: 2021-12-01
• First posted: 2021-04-08
• Last updated: 2021-04-08

Locations

1 site across 1 country: Israel