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Clinical Trials in the USA / NCT06163404
Active, not recruiting Not applicable

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

NCT06163404 · tracked via the Priya Life Science USA tracker
Sponsor
Spirair, Inc
Phase
Not applicable
Started
2023-11-01
Last updated
2026-03-30

Condition(s) studied

Nasal Septal DeviationNasal Airway Obstruction

Investigational drug(s) / intervention(s)

Implantation of Spirair Nasal Device using the Spirair delivery system.

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.

Study summary

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

Eligibility

Sex
ALL
Min age
21 Years
Max age
70 Years
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (8)

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

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06163404 on ClinicalTrials.gov ↗ ← All trials in the USA