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NCT06163404 · ClinicalTrials.gov registry record · NA
Open-Label Study to Evaluate the Safety and Effectiveness of the Spirair Implant
A NA study of Nasal Airway Obstruction and Nasal Septal Deviation, sponsored by Spirair.
- Active
- Registry status
- NA
- Development phase
- 102
- Enrollment target
- 8
- Study locations
NCT06163404: Active NA study of Nasal Airway Obstruction and Nasal Septal Deviation, sponsored by Spirair.
NCT06163404 is a NA study of Nasal Airway Obstruction and Nasal Septal Deviation that is active but no longer recruiting, run by Spirair. The registered enrollment target is 102 participants, below the 158-participant average among 3 other Nasal Airway Obstruction trials with a reported enrollment target (35% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06163404, a NA study of Nasal Airway Obstruction and Nasal Septal Deviation, is active but no longer recruiting, sponsored by Spirair.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 102 participants
- Enrollment target
- 8
- Study locations
Study Summary
Pilot study of bioabsorbable implant and delivery device for correction of septal deviation.
Primary Outcome
Percent change in Nasal Obstruction Septoplasty Effectiveness scale (NOSE) improvement at Month 3 compared to baseline.
Conditions Studied
Interventions
- DEVICE Implantation of Spirair Nasal Device using the Spirair delivery system.
Study Locations (8)
Louisiana
- Sinus and Nasal Specialists of LA - Baton Rouge
- Tandem Clinical Research - Marrero
Alabama
- Alabama Nasal and Sinus Center - Birmingham
California
- Breathe Clear Institute - Torrance
Kentucky
- Kentuckiana Ear, Nose & Throat - Louisville
New York
- Albany ENT & Allergy Services, PC - Albany
Pennsylvania
- Specialty Physicians - Bethlehem
Washington
- Ear Nose Throat & Allergy Associates - Puyallup
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2023-11-01 |
| Est. Completion | 2027-05 |
| Phase | NA |
What the registry record for NCT06163404 still lists
NCT06163404 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 158-participant average among 3 other Nasal Airway Obstruction trials with a reported enrollment target (35% lower).
The record links to 2 conditions, with Nasal Airway Obstruction appearing as the primary indexed condition, and to 1 intervention - of which Implantation of Spirair Nasal Device using the Spirair delivery system. is the first listed.
NCT06163404 lists 8 locations in 7 states (Louisiana, Alabama, California).
Frequently Asked Questions
What is clinical trial NCT06163404 about?
NCT06163404 is a clinical study titled "Open-Label Study to Evaluate the Safety and Effectiveness of the Spirair Implant". Pilot study of bioabsorbable implant and delivery device for correction of septal deviation.
What is the current status of trial NCT06163404?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 102 participants. The study started on 2023-11-01. Estimated completion is 2027-05.
What conditions does trial NCT06163404 study?
This clinical trial studies the following conditions: Nasal Airway Obstruction, Nasal Septal Deviation.
What interventions are being tested in trial NCT06163404?
The interventions under investigation include: Implantation of Spirair Nasal Device using the Spirair delivery system. (DEVICE).
Who is sponsoring clinical trial NCT06163404?
This trial is sponsored by Spirair, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06163404 being conducted?
This trial has 8 study locations across Alabama, California, Kentucky, Louisiana, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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