Active — Not RecruitingNot Applicable

A Prospective Study Comparing VivAer to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction.

United States400 participantsStarted 2025-02-28

Plain-language summary

The purpose of this study is to compare the clinical outcomes of the VivAer procedure to functional rhinoplasty and septoplasty surgery for the treatment of nasal airway obstruction (NAO) to establish non-inferiority.

Who can participate

Age range22 Years – 85 Years

SexALL

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Inclusion criteria

✓. VivAer procedure for repair of nasal valve dysfunction (may include inferior turbinate and septal swell body as additional treated areas)
✓. Functional rhinoplasty surgery addressing the nasal valve and/or lateral nasal wall (may be combined with septoplasty with/without turbinoplasty performed alone or in combination).
✓. Septoplasty surgery with turbinate reduction.

What they're measuring

Nasal Obstruction Symptom Evaluation (NOSE) Scale

Timeframe: 3 months, 6 months, 12 months and 24 months post-procedure.

Trial details

NCT IDNCT06922955

SponsorAerin Medical

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-06

View on ClinicalTrials.gov More Nasal Airway Obstruction trials