Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-24 @ 10:53 PM
Study NCT ID:
NCT05967169
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-02
First Post:
2023-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EFS of Bioabsorbable Implant for NSD
Sponsor:
Spirair, Inc
Organization:
Study Overview
Official Title:
Early Feasibility Study of Bioabsorbable Polydioxanone Implant and Delivery Device for Correction of Cartilaginous Septal Deviation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-03
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:
Early feasibility study of bioabsorbable implant and delivery device for correction of septal deviation
Detailed Description:
To obtain safety, device performance, patient tolerability and effectiveness outcome data in participants with cartilaginous septal deviations undergoing placement of the Spirair Implant with the Spirair delivery device.
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?:
False
Is an FDA AA801 Violation?: