Ignite Creation Date:
2024-05-06 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05945186
Status:
RECRUITING
Last Update Posted:
2023-07-14
First Post:
2023-07-06
Brief Title:
Design Validation Hemodynamic Study of New Kendall SCD SmartFlow Compression System
Sponsor:
Cardinal Health
Organization:
Cardinal Health
Study Overview
Official Title:
Design Validation Hemodynamic Study of New Kendall SCD SmartFlow Compression System With Cardinal Health Element Compression Sleeves
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
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:
This study is being conducted to evaluate the hemodynamic performance ie flow of blood in the legs using the new Kendall SCD SmartFlow compression system with Cardinal Health Element compression sleeves
Detailed Description:
This study is being conducted to evaluate hemodynamic performance using the new Kendall SCD SmartFlow compression system with Cardinal Health Element compression sleeves The study is intended to confirm the systems ability to increase venous blood flow over baseline as measured by blood velocity time average mean velocity and total volume flow in both the femoral and popliteal veins
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None