Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06460155
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-05-07
Brief Title:
CompuFlo CathCheck
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
CompuFlo CathCheck Using Pulse Wave Analysis Versus the Epidurogram for Determining Epidural Catheter Location A Crossover Study
Status:
RECRUITING
Status Verified Date:
2024-10
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:
The purpose of this study is to determine if the Compuflo CathCheck system is equivalent to an epidurogram in determining epidural catheter location in or outside the epidural space using the epidurogram as the gold standard In short this will be completed by performing an epidurogram as is standard of practice and the gold standard of determining epidural placement and compare it to the results of the Compuflo CathCheck system Equivalency will be summarized through agreement and concordance Additionally secondary outcomes will look at how classical physical exam findings to confirm epidural placement correlate and compare to epidurogram and Compuflo CathCheck findings
Detailed Description:
None
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