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

Study Overview
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Brief Summary
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Pilot study of bioabsorbable implant and delivery device for correction of septal deviation.

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

Official Title
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A Prospective, Multi-Center, Open-Label Study to Evaluate the Safety and Effectiveness of the Spirair Implant for Correction of Cartilaginous Nasal Septal Deviation

Conditions
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Nasal Septal Deviation, Nasal Airway Obstruction

Intervention / Treatment
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* Device: Implantation of Spirair Nasal Device using the Spirair delivery system.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥21 to ≤ 64 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Device: Spirair NSD system for minimally invasive correction of nasal septal deviation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Device<br>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.<br>* 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.<br>* Other names: SeptAlign;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Endpoint - 1 | Mean change in Nasal Obstruction Septoplasty Effectiveness Scale (NOSE) from baseline. | 12 Months | 
| Secondary Endpoint - 2 | Change in Sino-Nasal Outcomes Test (SNOT-22) from baseline. | 12 Months | 
| Secondary Endpoint - 3 | Change in Euro QOL Five Dimensions Questionnaire (EQ-5D-5L) from baseline. | 12 Months | 
| Secondary Endpoint - 4 | Change in Nasal Airway Obstruction (NAO) Visual Analog Scale (VAS) from baseline. | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NAO, Septal Deviation, Mobile Cartilaginous Nasal Septal Deviation