Sinus Endoscopic SurgeryGaiaNCT07027267

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

A study testing Implantation of Spirair device into the middle turbinates and TurbAlign in people with Sinus Endoscopic Surgery and Turbinate, run by Spirair, Inc at 5 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Sinus Endoscopic Surgery, Turbinate
What is being tested?: Implantation of Spirair device into the middle turbinates and TurbAlign
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 5 sitesUnited States
Study dates: 4 Aug 2025to 31 Jul 2026
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥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

Who cannot join

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

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

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

Other trials in United States

About this study

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)

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

Read the 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
Being tested: Implantation of Spirair device into the middle turbinates, TurbAlign
Keywords: Sinus surgery, FESS, middle turbinate, TurbAlign

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Implantation of Spirair device into the middle turbinatesDevice
Also called 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.
TurbAlignDevice
The Spirair implant is designed to separate the middle turbinate from the lateral nasal wall during the healing phase associated with nasal/sinus surgery

Study groups in NCT07027267
Study group	Role	What they receive
Open-label	Experimental	Treatment with the Spirair device as a treatment for medialization of the middle turbinates Receives: Device: Implantation of Spirair device into the middle turbinates; Device: TurbAlign

What is being measured

The primary outcome is the main question the study is designed to answer.

Miller Synechia Score
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.
Measured: 8 Weeks

Secondary outcomes (3)

Middle Turbinate Position Grade
Rate of avoidance of the middle turbinate lateralization at 4 and 8 weeks using Middle Turbinate Position Grade
Measured: 4 and 8 weeks
Miller Synechia Score
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
Measured: 4 weeks
Inflammation assessment
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
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Aug 202531 Jul 2026

First posted18 Jun 2025
Study start4 Aug 2025
Primary completion5 May 2026 (estimated)
Study completion31 Jul 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Sinus Endoscopic SurgeryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07027267
Sponsor's protocol ID: CT-004
Acronym: Gaia
Status last verified: Apr 2026
First submitted: 3 Jun 2025
Last updated: 27 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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