Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2025-12-17 @ 3:02 PM
Study NCT ID:
NCT04837560
Status:
None
Last Update Posted:
2021-04-08 00:00:00
First Post:
2021-04-06 00:00:00
Brief Title:
Safety and Efficacy of the ElastiMed's SACS 2.0 - Smart Active Compression Stocking for the Treatment of Venous Edema
Sponsor:
ElastiMed ltd
Organization:
ElastiMed ltd
Study Overview
Official Title:
Safety and Efficacy of the ElastiMed's SACS 2.0 - Smart Active Compression Stocking
Status:
None
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None