Ignite Creation Date:
2024-05-06 @ 2:00 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01940354
Status:
COMPLETED
Last Update Posted:
2017-11-09
First Post:
2013-09-03
Brief Title:
Comparison of AccuCath IV Catheter and Conventional IV Catheter in Interventional Radiology
Sponsor:
C R Bard
Organization:
C R Bard
Study Overview
Official Title:
A Prospective Randomized Controlled Comparison of First Attempt Success Between the AccuCath Intravenous System With Retractable Coiled Tip Guide Wire and Conventional Peripheral Intravenous Catheters With Interventional Radiology Nurses
Status:
COMPLETED
Status Verified Date:
2017-10
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 study will test a hypothesis that the AccuCath System will have a higher rate of successful first attempt peripheral IV placement and higher clinician and patient satisfaction compared to Conventional IV Catheters
Detailed Description:
This study is designed to evaluate userphysician preference as it relates to use of a 510k cleared vascular access peripheral IV catheter device compared with peripheral IV conventional needlecatheter devices in terms of first stick success rates adverse events and overall user and patient satisfaction As noted above the study is designed to formally test the hypothesis that the AccuCath System will exhibit superiority in terms of the rate of successful first attempt peripheral IV placement and higher user and patient satisfaction compared to Conventional IV Catheters
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None