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Safety and Effectiveness of TurbAlign™ for Middle Turbinate Medialization After Functional Endoscopic Sinus Surgery
Sponsor: Spirair, Inc
Summary
A study of a bioabsorbable implant to separate the middle turbinate from the lateral nasal wall associated with nasal/sinus surgery
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)
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2025-08-04
Completion Date
2026-07-31
Last Updated
2026-03-30
Healthy Volunteers
Yes
Conditions
Interventions
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.
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
Locations (5)
Northwest Community Hospital
Arlington Heights, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Tandem Clinical Research
Marrero, Louisiana, United States
LSU Health Science Center
Shreveport, Louisiana, United States
Houston Methodist ENT Specialists
Houston, Texas, United States