Pilot study of bioabsorbable implant and delivery device for correction of septal deviation.
To evaluate the safety and effectiveness of the Spirair Implant as a primary treatment for correction of cartilaginous nasal septal deviation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
102
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.
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
Primary Effectiveness Endpoint
Percent change in Nasal Obstruction Septoplasty Effectiveness scale (NOSE) improvement at Month 3 compared to baseline.
Time frame: 3 Months
Primary Safety Endpoint
Incidence of Serious Adverse Device Effects (SADEs), through Month 3.
Time frame: 3 Months
Secondary Endpoint - 1
Mean change in Nasal Obstruction Septoplasty Effectiveness Scale (NOSE) from baseline.
Time frame: 12 Months
Secondary Endpoint - 2
Change in Sino-Nasal Outcomes Test (SNOT-22) from baseline.
Time frame: 12 Months
Secondary Endpoint - 3
Change in Euro QOL Five Dimensions Questionnaire (EQ-5D-5L) from baseline.
Time frame: 12 Months
Secondary Endpoint - 4
Change in Nasal Airway Obstruction (NAO) Visual Analog Scale (VAS) from baseline.
Time frame: 12 Months
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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