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

Spirair

Status

Active, not recruiting

Conditions

Nasal Septal Deviation

Nasal Airway Obstruction

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT06163404

CT-002

Details and patient eligibility

About

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

Full description

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

Enrollment

102 patients

Sex

All

Ages

21 to 70 years old

Volunteers

No Healthy Volunteers

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)