Trials / Active Not Recruiting
Active Not RecruitingNCT06163404
Open-Label Study to Evaluate the Safety and Effectiveness of the Spirair Implant
A Prospective, Multi-Center, Open-Label Study to Evaluate the Safety and Effectiveness of the Spirair Implant for Correction of Cartilaginous Nasal Septal Deviation
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 102 (actual)
- Sponsor
- Spirair, Inc · Industry
- Sex
- All
- Age
- 21 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
Pilot study of bioabsorbable implant and delivery device for correction of septal deviation.
Detailed description
To evaluate the safety and effectiveness of the Spirair Implant as a primary treatment for correction of cartilaginous nasal septal deviation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-11-01
- Primary completion
- 2027-03-01
- Completion
- 2027-06-01
- First posted
- 2023-12-08
- Last updated
- 2026-03-30
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06163404. Inclusion in this directory is not an endorsement.