Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-25 @ 3:57 AM
Study NCT ID:
NCT04180202
Status:
TERMINATED
Last Update Posted:
2024-12-27
First Post:
2019-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Non-invasive Vs. Invasive Hemodynamic Measurements
Sponsor:
Nihon Kohden
Organization:
Study Overview
Official Title:
Comparison Study of EzCVP and CVP
Status:
TERMINATED
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated due to inability of clinical site to enroll sufficient number of subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Comparison of a non-invasive method of measuring central venous pressure to the conventional modality of invasive central venous pressure.
Detailed Description:
The conventional method used to measure central venous pressure has limitations since it is an invasive procedure that requires a central venous catheter. To overcome this challenge, a new technology to assess CVP non-invasively using an oscillometric method is being developed. It is called enclosed zone central venous pressure (ezCVP). A comparison study of ezCVP and CVP is needed to determine accuracy and reproducibility.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: