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

April 24, 2026 updated by: Spirair, Inc

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)

A study of a bioabsorbable implant to separate the middle turbinate from the lateral nasal wall associated with nasal/sinus surgery

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Northwest Community Hospital
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Tandem Clinical Research
      • Shreveport, Louisiana, United States, 71130
        • LSU Health Science Center
    • Texas
      • Houston, Texas, United States, 77030
        • Houston Methodist ENT Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ≥18 to ≤ 75 years of age at time of consent
  • Subject scheduled to undergo bilateral endoscopic sinus surgery
  • Willing and able to provide informed consent and comply with the study protocol

Exclusion Criteria:

  • History of removal of one or both middle turbinates
  • Presence of significant concha bullosa, which requires surgical excision
  • Presence of non-viable tissue at the implantation site
  • Active infection at the implantation site
  • Chronic nasal decongestant use (i.e. Afrin, etc)
  • Recreational intra-nasal drug use within 12 months of enrollment
  • Documented evidence of a history (e.g., liver testing) of drug/alcohol abuse within 12 months of enrollment
  • Hypersensitivity to any investigational device materials including known or suspected allergy to poly(dioxanone) (PDO) or other bioabsorbable materials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open-label
Treatment with the Spirair device as a treatment for medialization of the middle turbinates
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.
Other Names:
  • TurbAlign
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Miller Synechia Score
Time Frame: 8 Weeks
Rate of lateral synechia formation resulting in occlusion of the middle meatus at each turbinate (Miller Synechia Score of 2 or 3) observed at 8 weeks.
8 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Middle Turbinate Position Grade
Time Frame: 4 and 8 weeks
Rate of avoidance of the middle turbinate lateralization at 4 and 8 weeks using Middle Turbinate Position Grade
4 and 8 weeks
Miller Synechia Score
Time Frame: 4 weeks
Rate of lateral synechia formation resulting gin occlusion of the middle meatus at each turbinate (Miller Synechia Score of 2 or 3) observed at 4 weeks
4 weeks
Inflammation assessment
Time Frame: 8 weeks
Inflammation assessment of the gross tissue appearance at implantation site is assessed via live endoscopic video and graded I: None, II: Mild, III: Moderate, IV: Severe by investigator at 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spirair, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2025

Primary Completion (Estimated)

May 5, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

June 3, 2025

First Submitted That Met QC Criteria

June 10, 2025

First Posted (Actual)

June 18, 2025

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CT-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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