Ignite Creation Date:
2024-05-06 @ 6:12 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05572112
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-10-07
First Post:
2022-10-05
Brief Title:
The Performance Safety of the Celsite Venous Access Ports
Sponsor:
BBraun Médical - CoE Chasseneuil
Organization:
BBraun Médical - CoE Chasseneuil
Study Overview
Official Title:
Post Market Clinical Follow-up Study on the Performance Safety of Celsite Venous Access Ports in Patients Who Need Repeated Venous Access
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-10
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:
CAP
Brief Summary:
The Celsite Venous Access Ports System are intended to be used for repeated intravenous administration of for example chemotherapy antibiotic and antiviral drugs total parenteral nutrition blood sampling or transfusion
The objective is to assess the devices safety to deliver medication over the time in regard to the rate of adverse events related to the Celsite access ports written in the IFU
The objective is to assess the devices safety to deliver medication over the time in regard to the rate of adverse events related to the Celsite access ports written in the IFU
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None