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.
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
- Are there results?
- Not yet: the study is under way
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.
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
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Spirair, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07027267
- Acronym / sponsor ID
- Gaia / CT-004
- Conditions
- Sinus Endoscopic Surgery, Turbinate
- Keywords
- Sinus surgery, FESS, middle turbinate, TurbAlign
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Spirair, IncIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- 5 May 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label | Experimental | Device: Implantation of Spirair device into the middle turbinates, Device: TurbAlignTreatment with the Spirair device as a treatment for medialization of the middle turbinates |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of Spirair device into the middle turbinatesAlso: TurbAlignThe Spirair implant is designed to separate the middle turbinate from the lateral nasal wall during the healing phase associated with nasal/sinus surgery. | Device | Open-label |
| TurbAlignThe Spirair implant is designed to separate the middle turbinate from the lateral nasal wall during the healing phase associated with nasal/sinus surgery | Device | Open-label |
Primary outcome
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.
3 secondary outcomes
Middle Turbinate Position Grade
Time frame: 4 and 8 weeks
Miller Synechia Score
Time frame: 4 weeks
Inflammation assessment
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Miller Synechia Score (time frame: 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.