Nasal Septal DeviationNCT06163404
Open-Label Study to Evaluate the Safety and Effectiveness of the Spirair Implant
A study testing Implantation of Spirair Nasal Device using the Spirair delivery system. in people with Nasal Septal Deviation and Nasal Airway Obstruction, run by Spirair, Inc at 8 sites in United States.
Trial summary
Pilot study of bioabsorbable implant and delivery device for correction of septal deviation. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Nasal Septal Deviation, Nasal Airway Obstruction
- What is being tested?
- Implantation of Spirair Nasal Device using the Spirair delivery system.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Nov 2023to Jun 2027
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥21 to ≤ 70 years of age at time of consent
- Seeking treatment for nasal airway obstruction (NAO) symptoms due primarily to cartilaginous nasal septal deviation
- Willing to undergo a nasal implant procedure
- NOSE score ≥30 at Baseline Visit
- Non-calcified, mobile cartilaginous nasal septal deviation
Who cannot join
- Target nasal septal deviation that is calcified or non-mobile
- Previous septoplasty or rhinoplasty
- Having a concurrent ENT procedure, other than turbinate reduction
- Saddle nose deformity
- Congenital nasal defect
- Documented evidence that middle meatus is not visualized on endoscopic exam due to severe septal deviation
Show all 26Show fewer
- Turbinate reduction within the past six (6) months
- Permanent implant or dilator in the nose
- History of nasal vasculitis, unhealed wounds, cartilaginous nasal septal perforation or mucosal irregularities
- Active infection at the impllantation site e.g., folliculitis
- Current or chronic systemic steroid and/or has had radiation exposure or active chemotherapy in the treatment area
- Polyps or pathology, other than turbinate hypertrophy, that may be primary contributor to airway obstruction, in the opinion of the Investigator
- History of a significant bleeding disorder(s) and or taking current prescription blood thinner medication
- Hypersensitivity to any investigational device materials inclusing known or suspected allergy to poly(dioxanone) (PDO) or other bioabsorbable materials
- Major medical condition that could affect quality of life or wound healing and influence the results of the study (e.g., poorly controlled diabetes, HIV or other immunosuppressive conditions, active malignancy in the past 5 years, acute MI, CVA, etc.)
- Active smoker or history of tobacco or tobacco-related product use within the past 1 year
- Documented evidence of a history (e.g., liver testing) of drug/alcohol abuse within 12 months of enrollment
- Females of child-bearing potential who are either pregnant or breastfeeding or plan to become pregnant during the course of the study
- Currently participating, or plans to enroll in another clinical trial during this study or undergo another nasal septal treatment during study participation
- History of non-compliance with medical treatment or clinical trial participation
- Subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that the Investigator determines the subject to be unable or unlikely to comply with protocol required follow-up
- Any comorbidity or condition that renders the patient a poor surgical candidate as determined by the Investigator
- The subject is receiving prescription narcotic pain medication
- The subject's condition represents a worker's compensation case
- Symptoms of an upper respiratory infection e.g., runny nose, sneezing
- History of untreated or inadequately controlled rhinitis (allergic and/or nonallergic)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Albany ENT & Allergy Services, PC
Albany, New York, 12205
Sinus and Nasal Specialists of LA
Baton Rouge, Louisiana, 70809
Specialty Physicians
Bethlehem, Pennsylvania, 18017
Alabama Nasal and Sinus Center
Birmingham, Alabama, 35242
Kentuckiana Ear, Nose & Throat
Louisville, Kentucky, 40241
Tandem Clinical Research
Marrero, Louisiana, 70072
Ear Nose Throat & Allergy Associates
Puyallup, Washington, 98374
Breathe Clear Institute
Torrance, California, 90503
About this study
Official title: A Prospective, Multi-Center, Open-Label Study to Evaluate the Safety and Effectiveness of the Spirair Implant for Correction of Cartilaginous Nasal Septal Deviation
Pilot study of bioabsorbable implant and delivery device for correction of septal deviation.
Read the detailed description
To evaluate the safety and effectiveness of the Spirair Implant as a primary treatment for correction of cartilaginous nasal septal deviation.
- Conditions
- Nasal Septal Deviation, Nasal Airway Obstruction
- Being tested
- Implantation of Spirair Nasal Device using the Spirair delivery system.
- Keywords
- NAO, Septal Deviation, Mobile Cartilaginous Nasal Septal Deviation
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of Spirair Nasal Device using the Spirair delivery system.Device
Also called SeptAlign
The Spirair implant is designed to acutely correct cartilaginous septal deviation and maintain the cartilage in a corrected position for a duration sufficient to allow for cartilaginous remodeling.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Device | Experimental | Treatment with the Spirair Septal correction device and delivery system for correction of cartilaginous nasal septal deviation. Receives: Device: Implantation of Spirair Nasal Device using the Spirair delivery system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint
Percent change in Nasal Obstruction Septoplasty Effectiveness scale (NOSE) improvement at Month 3 compared to baseline.
Measured: 3 Months
Primary Safety Endpoint
Incidence of Serious Adverse Device Effects (SADEs), through Month 3.
Measured: 3 Months
Secondary outcomes (4)
Secondary Endpoint - 1
Mean change in Nasal Obstruction Septoplasty Effectiveness Scale (NOSE) from baseline.
Measured: 12 Months
Secondary Endpoint - 2
Change in Sino-Nasal Outcomes Test (SNOT-22) from baseline.
Measured: 12 Months
Secondary Endpoint - 3
Change in Euro QOL Five Dimensions Questionnaire (EQ-5D-5L) from baseline.
Measured: 12 Months
Secondary Endpoint - 4
Change in Nasal Airway Obstruction (NAO) Visual Analog Scale (VAS) from baseline.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start1 Nov 2023
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal Septal DeviationStudies 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
- Model description
- Device: Spirair NSD system for minimally invasive correction of nasal septal deviation.
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spirair, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brandon McCutcheon, MD, Study director, Spirair, CMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163404
- Sponsor's protocol ID
- CT-002
- Status last verified
- Mar 2026
- First submitted
- 30 Nov 2023
- Last updated
- 30 Mar 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 30 Mar 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 the Spirair Implant for Correction of Cartilaginous Nasal Septal Deviation
- ClinicalTrials.gov ID
- NCT06163404
- Acronym / sponsor ID
- CT-002
- Conditions
- Nasal Septal Deviation, Nasal Airway Obstruction
- Keywords
- NAO, Septal Deviation, Mobile Cartilaginous Nasal Septal Deviation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Spirair, IncIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 8 Dec 2023 (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.
Pilot study of bioabsorbable implant and delivery device for correction of septal deviation.
Detailed description
To evaluate the safety and effectiveness of the Spirair Implant as a primary treatment for correction of cartilaginous nasal septal deviation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Device: Spirair NSD system for minimally invasive correction of nasal septal deviation.
| Arm | Type | Receives |
|---|---|---|
| Investigational Device | Experimental | Device: Implantation of Spirair Nasal Device using the Spirair delivery system.Treatment with the Spirair Septal correction device and delivery system for correction of cartilaginous nasal septal deviation. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥21 to ≤ 70 years of age at time of consent
- Seeking treatment for nasal airway obstruction (NAO) symptoms due primarily to cartilaginous nasal septal deviation
- Willing to undergo a nasal implant procedure
- NOSE score ≥30 at Baseline Visit
- Non-calcified, mobile cartilaginous nasal septal deviation
Key exclusion criteria (26 listed)
- Target nasal septal deviation that is calcified or non-mobile
- Previous septoplasty or rhinoplasty
- Having a concurrent ENT procedure, other than turbinate reduction
- Saddle nose deformity
- Congenital nasal defect
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 Nasal Device using the Spirair delivery system.Also: SeptAlignThe Spirair implant is designed to acutely correct cartilaginous septal deviation and maintain the cartilage in a corrected position for a duration sufficient to allow for cartilaginous remodeling. | Device | Investigational Device |
Primary outcome
Primary Effectiveness Endpoint
Time frame: 3 Months
Percent change in Nasal Obstruction Septoplasty Effectiveness scale (NOSE) improvement at Month 3 compared to baseline.
Primary Safety Endpoint
Time frame: 3 Months
Incidence of Serious Adverse Device Effects (SADEs), through Month 3.
4 secondary outcomes
Secondary Endpoint - 1
Time frame: 12 Months
Secondary Endpoint - 2
Time frame: 12 Months
Secondary Endpoint - 3
Time frame: 12 Months
Secondary Endpoint - 4
Time frame: 12 Months
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 30 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Nasal Septal Deviation
Not yet recruitingObservational study
Clinicoradiological Correlation Between Long Standing Untreated Adenoids and Nasal Septum Deviation in Adolescents
Nasal Septum Deviation
Recruiting
Comparative Study - Transseptal Suture Technique Verses Anterior Nasal Packing After Septoplasty
Deviated Nasal Septum, Postoperative Nasal Pain
Not yet recruiting
Evaluation of the Outcome of Septoplasty With or Without Inferior Turbinate Reduction
Deviated Nasal Septum, Nasal Obstruction Septal Deviation Compensatory Inferior Turbinate Hypertrophy
Not yet recruitingObservational study
Effect of Controlled Hypotension on GFAP and Cognition in Rhinoplasty
Nasal Septum Deviation, Rhinoplasty
Active, not recruitingObservational study
Comparison of Laryngeal Mask and Tracheal Intubation With and Without Topical Lidocaine Application
Comparison of Airway Management Techniques in Functional Endoscopic Sinus Surgery, Rhinosinusitis With Polyps
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.
Brandon McCutcheon, MD study director
Spirair, CMO
8 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 Nasal Device using the Spirair delivery system. in people with Nasal Septal Deviation and Nasal Airway Obstruction, run by Spirair, Inc at 8 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 5 inclusion and 26 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 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Primary Effectiveness Endpoint (time frame: 3 Months). The study lists 2 primary outcomes in all. 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 30 Mar 2026.