Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05925985
Status:
RECRUITING
Last Update Posted:
2024-02-14
First Post:
2023-05-19
Brief Title:
Propel Drug-Eluting Sinus Stent Family Open Cohort
Sponsor:
Medtronic
Organization:
Medtronic
Study Overview
Official Title:
Propel Drug-Eluting Sinus Stent Family Open Cohort
Status:
RECRUITING
Status Verified Date:
2024-02
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 purpose of this study is to confirm the long-term clinical safety and performance acceptability of identified risks and to detect emerging risks based on factual evidence for the PROPEL family of products when used according to labeling in patients with chronic rhinosinusitis CRS undergoing sinus surgery Additionally this study intends to collect data on use of corticosteroid-eluting implants in the European CRS population Data collected will be used to ensure continued consistency between clinical data the information materials supplied by the manufacturer and the risk management documentation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None