N/A
Completed N=122
Study of the AERin Medical Vivaer® ARC Stylus for Nasal AirWAY Obstruction
Source: ClinicalTrials.gov NCT04277507 ↗Enrolled (actual)
122
Serious AEs
0.8%
Results posted
May 2023
Primary outcomePrimary: Change in Nasal Obstructive Symptom Evaluation (NOSE) Scores From Baseline to 3 Months — -47.6 score on a scale
Summary
Post-market study to continue to evaluate the effectiveness of the Vivaer® ARC Stylus for nasal airway obstruction
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Nasal Obstructive Symptom Evaluation (NOSE) Scores From Baseline to 3 Months |
-47.6 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 or older
- Willing and able to provide informed consent
- Willing and able to comply with the study protocol
- Seeking treatment for nasal obstruction
- NOSE score of ≥ 60 at Baseline
- Nasal valve is a primary or significant contributor to the subject's nasal obstruction as determined by the study investigator (based on clinical presentation, physical examination, nasal endoscopy, etc.) and the subject has a positive response to any of the following temporary measures (based on patient history or office exam):
- Use of external nasal dilator strips (e.g., Breathe Right Strips)
- Q-Tip test (manual intranasal lateralization)
- Use of nasal stents
- Cottle Maneuver (manual lateral retraction of the cheek)
Exclusion Criteria
- Prior surgical treatment of the nasal valve
- Rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past three (3) months
- Anatomy that requires an adjunctive surgical nasal procedure on the same day or 3 months after the Vivaer procedure
- Medical conditions which in the opinion of the treating physician would predispose the subject to poor wound healing or increased surgical risk.
Data sourced from ClinicalTrials.gov (NCT04277507). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.