Open-Label Study to Evaluate the Safety and Effectiveness of the Spirair Implant

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Nasal Airway Obstruction; Nasal Septal Deviation
• Intervention / Treatment: Device: Implantation of Spirair Nasal Device using the Spirair delivery system.

Detailed Description

To evaluate the safety and effectiveness of the Spirair Implant as a primary treatment for correction of cartilaginous nasal septal deviation.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35242
      • Alabama Nasal and Sinus Center
  • California
    • Torrance, California, United States, 90503
      • Breathe Clear Institute
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Kentuckiana Ear, Nose & Throat
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Sinus and Nasal Specialists of LA
    • Marrero, Louisiana, United States, 70072
      • Tandem Clinical Research
  • New York
    • Albany, New York, United States, 12205
      • Albany ENT & Allergy Services, PC
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18017
      • Specialty Physicians
  • Washington
    • Puyallup, Washington, United States, 98374
      • Ear Nose Throat & Allergy Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ≥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

Exclusion Criteria:

• 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
• 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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational Device; Treatment with the Spirair Septal correction device and delivery system for correction of cartilaginous nasal septal deviation.	Device: Implantation of Spirair Nasal Device using the Spirair delivery system.; 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.; Other Names: SeptAlign

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Effectiveness Endpoint	Percent change in Nasal Obstruction Septoplasty Effectiveness scale (NOSE) improvement at Month 3 compared to baseline.	3 Months
Primary Safety Endpoint	Incidence of Serious Adverse Device Effects (SADEs), through Month 3.	3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Endpoint - 1	Mean change in Nasal Obstruction Septoplasty Effectiveness Scale (NOSE) from baseline.	12 Months
Secondary Endpoint - 2	Change in Sino-Nasal Outcomes Test (SNOT-22) from baseline.	12 Months
Secondary Endpoint - 3	Change in Euro QOL Five Dimensions Questionnaire (EQ-5D-5L) from baseline.	12 Months
Secondary Endpoint - 4	Change in Nasal Airway Obstruction (NAO) Visual Analog Scale (VAS) from baseline.	12 Months

Collaborators and Investigators

• Sponsor: Spirair, Inc
• Investigators: Study Director: Brandon McCutcheon, MD, Spirair, CMO

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Actual): December 8, 2023

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: NAO; Septal Deviation; Mobile Cartilaginous Nasal Septal Deviation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Nose Diseases; Otorhinolaryngologic Diseases; Respiratory Insufficiency; Airway Obstruction; Nasal Obstruction
• Other Study ID Numbers: CT-002

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