Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-27 @ 1:11 AM
Study NCT ID:
NCT01054703
Status:
TERMINATED
Last Update Posted:
2024-08-06
First Post:
2010-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of the Ethmoid Sinus Spacer
Sponsor:
Integra LifeSciences Corporation
Organization:
Study Overview
Official Title:
Clinical Evaluation of the Safety and Feasibility of the Ethmoid Sinus Spacer and Access System With Drug (SPACER)
Status:
TERMINATED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Interim assessment performed after 14 patients provided evidence that further enrollment was not required to achieve intended endpoints of the study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPACER
Brief Summary:
Evaluation of treatment of the ethmoid sinuses with the Ethmoid Sinus Spacer and Access system
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
None
Is an FDA AA801 Violation?: