N/A N=122 Treatment

Study of the AERin Medical Vivaer® ARC Stylus for Nasal AirWAY Obstruction

Nasal Obstruction

Bottom Line

View on ClinicalTrials.gov: NCT04277507 ↗

Enrolled (actual)

122

Serious AEs

0.8%

Results posted

May 2023

Primary outcome: Primary: Change in Nasal Obstructive Symptom Evaluation (NOSE) Scores From Baseline to 3 Months — -47.6 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Vivaer Stylus (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Aerin Medical
Primary completion: Dec 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Nasal Obstructive Symptom Evaluation (NOSE) Scores From Baseline to 3 Months	-47.6	—

Summary

Post-market study to continue to evaluate the effectiveness of the Vivaer® ARC Stylus for nasal airway obstruction

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.

View full record on ClinicalTrials.gov →

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.