Open-Label Study to Evaluate the Safety and Effectiveness of the Spirair Implant (NCT06163404) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Open-Label Study to Evaluate the Safety and Effectiveness of the Spirair Implant
United States102 participantsStarted 2023-11-01
Plain-language summary
Pilot study of bioabsorbable implant and delivery device for correction of septal deviation.
Who can participate
Age range21 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 condit…