Ignite Creation Date:
2024-05-06 @ 4:05 AM
Last Modification Date:
2024-10-26 @ 11:43 AM
Study NCT ID:
NCT02449798
Status:
COMPLETED
Last Update Posted:
2017-04-14
First Post:
2015-05-16
Brief Title:
Prospective Feasibility Trial of AccuCath 225 Blood Control BC Placed in Difficult Access Patients in the Emergency Department
Sponsor:
C R Bard
Organization:
C R Bard
Study Overview
Official Title:
A Prospective Feasibility Trial of AccuCath 225 BC Intravascular Catheter System With Retractable Coiled Tip Guidewire Placed in Difficult Access Patients in the Emergency Department
Status:
COMPLETED
Status Verified Date:
2017-03
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:
Study objective is to evaluate user preference time for procedure insertion success rates complications completion of therapy and dwell time of the AccuCath 225 BC device placed in difficult IV access patients in the emergency department
Detailed Description:
A one arm prospective feasibility study using the AccuCath 225 BC Intravascular Catheter System placed in the upper arm with ultrasound guidance and the lower arm with and without ultrasound guidance based on clinical assessment Subjects will be subjected to a maximum of 4 attempts If unsuccessful by the 4th attempt alternatives will be considered as per current standard of care
Currently multiple IV attempts are made in difficult IV access patients without success Patients are often escalated to more invasive lines due to the need for longer catheters without clinical indication The study will evaluate the feasibility of AccuCath 225 BC as a low risk lower cost alternative for this patient population in lieu of using a midline peripherally inserted central line or central venous catheter when not clinically required for purposes of therapy
Currently multiple IV attempts are made in difficult IV access patients without success Patients are often escalated to more invasive lines due to the need for longer catheters without clinical indication The study will evaluate the feasibility of AccuCath 225 BC as a low risk lower cost alternative for this patient population in lieu of using a midline peripherally inserted central line or central venous catheter when not clinically required for purposes of therapy
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