Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:36 PM
Study NCT ID:
NCT06163404
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-30
First Post:
2023-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Open-Label Study to Evaluate the Safety and Effectiveness of the Spirair Implant
Sponsor:
Spirair, Inc
Organization:
Study Overview
Official Title:
A Prospective, Multi-Center, Open-Label Study to Evaluate the Safety and Effectiveness of the Spirair Implant for Correction of Cartilaginous Nasal 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:
Pilot study of bioabsorbable implant and delivery device for correction of septal deviation.
Detailed Description:
To evaluate the safety and effectiveness of the Spirair Implant as a primary treatment for correction of cartilaginous nasal septal deviation.
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?: