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

Running, not enrolling · Not applicable

Conditions studied: Nasal Septal Deviation, Nasal Airway Obstruction

In brief

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

Key facts

Study ID

NCT06163404

Run by

Spirair, Inc

People needed

102

Starts

2023-11-01

Expected to finish

2027-06-01

Last updated by the study team

2026-03-30

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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.)
• 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

Where it is running

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

Full record on ClinicalTrials.gov

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