NCT07027267

Safety and Effectiveness of TurbAlign™ for Middle Turbinate Medialization After Functional Endoscopic Sinus Surgery

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: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Spirair, Inc · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sinus Endoscopic Surgery
• Turbinate

Interventions

Type	Name	Description
DEVICE	Implantation of Spirair device into the middle turbinates	The Spirair implant is designed to separate the middle turbinate from the lateral nasal wall during the healing phase associated with nasal/sinus surgery.
DEVICE	TurbAlign	The Spirair implant is designed to separate the middle turbinate from the lateral nasal wall during the healing phase associated with nasal/sinus surgery

Timeline

• Start date: 2025-08-04
• Primary completion: 2026-05-05
• Completion: 2026-07-31
• First posted: 2025-06-18
• Last updated: 2026-03-30

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study