Nasal Septal DeviationNCT05967169
EFS of Bioabsorbable Implant for NSD
A study testing Nasal Septal Strap implantation in people with Nasal Septal Deviation, run by Spirair, Inc at 2 sites in United States.
Trial summary
Early feasibility study of bioabsorbable implant and delivery device for correction of septal deviation Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Nasal Septal Deviation
- What is being tested?
- Nasal Septal Strap implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 May 2022to 23 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-calcified, mobile cartilaginous septal deviation.
- ≥21 years of age.
- Willing and able to provide informed consent and comply with the study protocol.
- Seeking treatment for nasal airway obstruction (NAO) due to septal deviation and is willing to undergo a nasal implant procedure.
- Type I, II, or III septal deviation as defined by 7-Degree Mladina classification scheme
- NOSE score ≥30 at Screening Visit.
- Appropriate nasal anatomy to receive the implant(s).
Who cannot join
- Type IV, V, VI or VII septal deviation as defined by 7-Degree Mladina classification scheme (See Table 2) or other non-cartilaginous septum anatomical pathology identified on CT scan suspected by Investigator to be the primary contributor to NAO.
- Having a concurrent ENT procedure, other than turbinate reduction.
- Previous septoplasty or rhinoplasty.
- Has had turbinate reduction or other nasal surgeries within the past six (6) months.
- Plans to have any surgical or non-surgical treatment of their nasal septum, other than the index procedure, within six (6) months of the procedure.
- Permanent implant or dilator in the nasal area.
Show all 22Show fewer
- Concomitant autoimmune, inflammatory, or infectious skin conditions, unhealed wounds, septal perforation, or mucosal irregularities in the treatment area.
- Currently has active nasal vestibulitis or folliculitis.
- History of nasal vasculitis.
- Current or chronic systemic steroid and/or recreational intra-nasal drug user.
- Has had a cancerous or pre-cancerous lesion and/or has had radiation exposure in the treatment area or active chemotherapy.
- 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 current prescription blood thinner medication that would prevent healing of the treatment area post procedure.
- Known or suspected allergy to polydioxanone or other absorbable materials.
- Significant systemic disease such as poorly controlled diabetes or connective tissue disease which, in the investigator's opinion, could pre-dispose the participant to poor wound healing.
- Current tobacco or tobacco-related product use or history within the past 10 years of heavy smoking (on average, more than half a pack of cigarettes per day).
- Female participants of childbearing potential who are known or suspected to be pregnant and/or lactating.
- Any physical condition that, in the Investigator's opinion, would prevent adequate study participation or increase risk.
- Additionally, for OR cases (Cohorts 1 or 3) any individual who meets the following criteria will be ineligible for enrollment as an OR case
- Is not a candidate for procedures conducted under general anesthesia.
- Additionally, for in-office cases (Cohort 2) any individual who meets the following criteria will be ineligible for enrollment as an in-office case:
- s not a candidate for procedures conducted under local anesthesia alone.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Specialty Physicians
Bethlehem, Pennsylvania, 18017
Breathe Clear Institute
Torrance, California, 90503
About this study
Official title: Early Feasibility Study of Bioabsorbable Polydioxanone Implant and Delivery Device for Correction of Cartilaginous Septal Deviation
Early feasibility study of bioabsorbable implant and delivery device for correction of septal deviation
Read the detailed description
To obtain safety, device performance, patient tolerability and effectiveness outcome data in participants with cartilaginous septal deviations undergoing placement of the Spirair Implant with the Spirair delivery device.
- Conditions
- Nasal Septal Deviation
- Being tested
- Nasal Septal Strap implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal Septal Strap implantationDevice
Correction of NSD with Nasal Septal Strap implant
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Index Procedure in OR, placement of one implant Receives: Device: Nasal Septal Strap implantation |
| Cohort 2 | Experimental | Index Procedure in office or OR, placement of one implant Receives: Device: Nasal Septal Strap implantation |
| Cohort 3 | Experimental | Index Procedure in OR, placement of up to two implant Receives: Device: Nasal Septal Strap implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with successful implantation as measured through physician's assessment and patient reported outcomes
Feasibility of implantation and durability of Implant through the healing process
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start25 May 2022
- Primary completion16 Oct 2025
- Study completion23 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Multi-cohort
- Masking
- None (open label)
- Enrolment
- 21 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
- NCT05967169
- Sponsor's protocol ID
- CT-001
- Status last verified
- Apr 2026
- First submitted
- 13 Jul 2023
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Davis SE, Davis GE. The Safety and Efficacy of a Bioabsorbable Implant for Correction of Cartilaginous Septal Deviation. Ear Nose Throat J. 2025 Jun 4:1455613251346589. doi: 10.1177/01455613251346589. Online ahead of print.
PubMed 40468718
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study of Bioabsorbable Polydioxanone Implant and Delivery Device for Correction of Cartilaginous Septal Deviation
- ClinicalTrials.gov ID
- NCT05967169
- Acronym / sponsor ID
- CT-001
- Conditions
- Nasal Septal Deviation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Spirair, IncIndustry (pharma, biotech, devices)
- Study start
- 25 May 2022 (actual)
- Primary completion
- 16 Oct 2025 (actual)
- Study completion
- 23 Mar 2026 (actual)
- First posted
- 1 Aug 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.
Early feasibility study of bioabsorbable implant and delivery device for correction of septal deviation
Detailed description
To obtain safety, device performance, patient tolerability and effectiveness outcome data in participants with cartilaginous septal deviations undergoing placement of the Spirair Implant with the Spirair delivery device.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Multi-cohort
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Device: Nasal Septal Strap implantationIndex Procedure in OR, placement of one implant |
| Cohort 2 | Experimental | Device: Nasal Septal Strap implantationIndex Procedure in office or OR, placement of one implant |
| Cohort 3 | Experimental | Device: Nasal Septal Strap implantationIndex Procedure in OR, placement of up to two implant |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Non-calcified, mobile cartilaginous septal deviation.
- ≥21 years of age.
- Willing and able to provide informed consent and comply with the study protocol.
- Seeking treatment for nasal airway obstruction (NAO) due to septal deviation and is willing to undergo a nasal implant procedure.
- Type I, II, or III septal deviation as defined by 7-Degree Mladina classification scheme
Key exclusion criteria (22 listed)
- Type IV, V, VI or VII septal deviation as defined by 7-Degree Mladina classification scheme (See Table 2) or other non-cartilaginous septum anatomical pathology identified on CT scan suspected by Investigator to be the primary contributor to NAO.
- Having a concurrent ENT procedure, other than turbinate reduction.
- Previous septoplasty or rhinoplasty.
- Has had turbinate reduction or other nasal surgeries within the past six (6) months.
- Plans to have any surgical or non-surgical treatment of their nasal septum, other than the index procedure, within six (6) months of the procedure.
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 |
|---|---|---|
| Nasal Septal Strap implantationCorrection of NSD with Nasal Septal Strap implant | Device | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Number of participants with successful implantation as measured through physician's assessment and patient reported outcomes
Time frame: 24 months
Feasibility of implantation and durability of Implant through the healing process
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Derived from this study: PubMed 40468718Davis SE, Davis GE. The Safety and Efficacy of a Bioabsorbable Implant for Correction of Cartilaginous Septal Deviation. Ear Nose Throat J. 2025 Jun 4:1455613251346589. doi: 10.1177/01455613251346589. Online ahead of print.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal Septal Strap implantation in people with Nasal Septal Deviation, run by Spirair, Inc at 2 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 7 inclusion and 22 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: finished, as of the sponsor's last update on 30 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 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with successful implantation as measured through physician's assessment and patient reported outcomes (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05967169, which also lists 1 linked publication.
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 Apr 2026.