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ACTIVE NOT RECRUITING
NCT07027267
NA

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

Sponsor: Spirair, Inc

View on ClinicalTrials.gov

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

Interventions

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

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