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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06163404
• Other study ID #: CT-002
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: Spirair, Inc
• Contact: Heather Neill
• Phone: 615-483-7438
• Email: heather[@]spirair.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• 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 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Obstruction
• Nasal Airway Obstruction
• Nasal Obstruction
• Nasal Septal Deviation

Intervention

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

Locations

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	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

Sponsors (1)

Lead Sponsor	Collaborator
Spirair, Inc

Country where clinical trial is conducted

United States, 

Outcome

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