Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632509
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
BD SiteRiteTM 9 Ultrasound System - Clinical Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
BD SiteRiteTM 9 Ultrasound System - 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 SiteRite 9 System 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 SiteRite 9 System Subjects will be recruited for participation based on need for Vascular Access Device VAD placement in a hospital setting
Enrolled subjects will go through ultrasound-guided Vascular Access Device USGVAD placement as part of their clinical care USGVAD 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 Vascular Access Device USGVAD placement as part of their clinical care USGVAD 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