Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632496
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
BD PrevueTM II Peripheral Vascular Access System with CueTM Needle Tracking Technology Clinical Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
BD PrevueTM II Peripheral Vascular Access System with CueTM Needle Tracking Technology Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This post-market study is being conducted to generate safety and performance data on the BD PrevueTM II Peripheral Vascular Access System with CueTM Needle Tracking Technology The data will be utilized to support regional registrations for example EU MDR and document any unforeseen residual risks
Detailed Description:
This is an observational post-market human subject study to evaluate the safety and performance of the BD PrevueTM II Peripheral Vascular Access System with CueTM Needle Tracking Technology Subjects will be recruited for participation based on need for IV catheter midline catheters included placement in a hospital setting
Enrolled subjects will go through ultrasound-guided peripheral intravenous catheter USGPIV placement as part of their clinical care USGPIV is defined as a procedure in which an ultrasound machine is used to assist a qualified health care provider with IV cannulation from skin puncture through venipuncture via direct visualization on the ultrasound machine in real time
Enrolled subjects will go through ultrasound-guided peripheral intravenous catheter USGPIV placement as part of their clinical care USGPIV is defined as a procedure in which an ultrasound machine is used to assist a qualified health care provider with IV cannulation from skin puncture through venipuncture via direct visualization on the ultrasound machine in real time
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