Nasal Airway Obstruction Clinical Trial
Official title:
A Prospective, Multi-Center, Open-Label Study to Evaluate the Safety and Effectiveness of the Spirair Implant for Correction of Cartilaginous Nasal Septal Deviation
NCT number | NCT06163404 |
Other study ID # | CT-002 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | November 1, 2023 |
Est. completion date | July 2025 |
Verified date | June 2024 |
Source | Spirair, Inc |
Contact | Margo Snyder |
Phone | 615-483-7438 |
margo[@]spirair.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Pilot study of bioabsorbable implant and delivery device for correction of septal deviation.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | July 2025 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Albany ENT & Allergy Services, PC | Albany | New York |
United States | The Centers for Advanced ENT Care, LLC | Baltimore | Maryland |
United States | Sinus and Nasal Specialists of Louisana | Baton Rouge | Louisiana |
United States | Specialty Physicians | Bethlehem | Pennsylvania |
United States | Alabama Nasal and Sinus Center | Birmingham | Alabama |
United States | Kentuckiana Ear, Nose & Throat | Louisville | Kentucky |
United States | Tandem Clinical Research | Marrero | Louisiana |
United States | Ear Nose Throat & Allergy Associates | Puyallup | Washington |
United States | Breathe Clear Institute | Torrance | California |
Lead Sponsor | Collaborator |
---|---|
Spirair, Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary Effectiveness Endpoint | Percent change in Nasal Obstruction Septoplasty Effectiveness scale (NOSE) improvement at Month 3 compared to baseline. | 3 Months | |
Primary | Primary Safety Endpoint | Incidence of Serious Adverse Device Effects (SADEs), through Month 3. | 3 Months | |
Secondary | Secondary Endpoint - 1 | Mean change in Nasal Obstruction Septoplasty Effectiveness Scale (NOSE) from baseline. | 12 Months | |
Secondary | Secondary Endpoint - 2 | Change in Sino-Nasal Outcomes Test (SNOT-22) from baseline. | 12 Months | |
Secondary | Secondary Endpoint - 3 | Change in Euro QOL Five Dimensions Questionnaire (EQ-5D-5L) from baseline. | 12 Months | |
Secondary | Secondary Endpoint - 4 | Change in Nasal Airway Obstruction (NAO) Visual Analog Scale (VAS) from baseline. | 12 Months |
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