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

NCT06163404 | Active Not Recruiting FDA Device

• 1 other identifier: CT-002
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 8

Brief Summary

Pilot study of bioabsorbable implant and delivery device for correction of septal deviation.

Conditions

Nasal Septal Deviation; Nasal Airway Obstruction

Keywords

NAO; Septal Deviation; Mobile Cartilaginous Nasal Septal Deviation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Secondary Endpoint - 1

  12 Months

• Secondary Endpoint - 2

  12 Months

• Secondary Endpoint - 3

  12 Months

• Secondary Endpoint - 4

  12 Months

Study Arms (1)

Investigational Device

EXPERIMENTAL

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.

Interventions

Implantation of Spirair Nasal Device using the Spirair delivery system. DEVICE

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.

Also known as: SeptAlign

Investigational Device

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Spirair, Inc: lead

Study Sites (8)

Alabama Nasal and Sinus Center

Birmingham, Alabama, 35242, United States

Location

Breathe Clear Institute

Torrance, California, 90503, United States

Location

Kentuckiana Ear, Nose & Throat

Louisville, Kentucky, 40241, United States

Location

Sinus and Nasal Specialists of LA

Baton Rouge, Louisiana, 70809, United States

Location

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

Location

Albany ENT & Allergy Services, PC

Albany, New York, 12205, United States

Location

Specialty Physicians

Bethlehem, Pennsylvania, 18017, United States

Location

Ear Nose Throat & Allergy Associates

Puyallup, Washington, 98374, United States

Location

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Study Officials

• Brandon McCutcheon, MD

  Spirair, CMO

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Device: Spirair NSD system for minimally invasive correction of nasal septal deviation.

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 8, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)