Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:37 PM
Study NCT ID:
NCT07027267
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-18
First Post:
2025-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness of TurbAlign™ for Middle Turbinate Medialization After Functional Endoscopic Sinus Surgery
Sponsor:
Spirair, Inc
Organization:
Study Overview
Official Title:
A Prospective, Multi-Center, Open-Label Study to Evaluate the Safety and Effectiveness of TurbAlign™ to Achieve Middle Turbinate Medialization After Functional Endoscopic Sinus Surgery (FESS) (GAIA)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
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:
Gaia
Brief Summary:
A study of a bioabsorbable implant to separate the middle turbinate from the lateral nasal wall associated with nasal/sinus surgery
Detailed Description:
To evaluate the safety and effectiveness of the Spirair implant as a primary treatment to achieve medialization of the middle turbinate after functional endoscopic sinus surgery.
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?: