Clinical trial NCT04277507: Study of the AERin Medical Vivaer® ARC Stylus for Nasal AirWAY Obstruction
Official title: A Prospective, Multicenter Study of the AERin Medical Vivaer® ARC Stylus for Nasal AirWAY Obstruction (AERWAY)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Obstruction
Keywords: Nasal valve
Nasal airway obstruction
Lead sponsor: Aerin Medical
Sponsor class: INDUSTRY
First posted: 2020-02-20
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: Prospective, Multicenter, Non-randomized Study of the Aerin Medical Vivaer® ARC Stylus for Nasal Airway Obstruction to continue to evaluate the effectiveness of the Vivaer® ARC Stylus for treating the nasal valve area to improve symptoms in those diagnosed with nasal airway obstruction.

Eligibility criteria: Inclusion Criteria:

1. Age 18 or older
2. Willing and able to provide informed consent
3. Willing and able to comply with the study protocol
4. Seeking treatment for nasal obstruction
5. NOSE score of ≥ 60 at Baseline
6. 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:

1. Prior surgical treatment of the nasal valve
2. Rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past three (3) months
3. Anatomy that requires an adjunctive surgical nasal procedure on the same day or 3 months after the Vivaer procedure
4. Medical conditions which in the opinion of the treating physician would predispose the subject to poor wound healing or increased surgical risk.

Primary outcomes:
measure: Change in Nasal Obstructive Symptom Evaluation (NOSE) Scores From Baseline to 3 Months
timeFrame: 3 Month
Secondary outcomes:
Other outcomes:
measure: Subject-reported Visual Analog Scale (VAS) Pain Scores in Relation to the Area Treated by the Study Procedure
timeFrame: 3 months post study procedure
measure: Subject Reported Change in Medication Use for Nasal Obstruction Symptoms
timeFrame: 24 Month
measure: Change in Nasal Obstructive Symptom Evaluation (NOSE)Scores From Baseline to 24 Months - Analysis
timeFrame: 24 Months
Locations:
city: Birmingham
country: United States
facility: Alabama Nasal and Sinus Center
state: Alabama
city: Goodyear
country: United States
facility: Arizona Desert ENT Specialists
state: Arizona
city: Roseville
country: United States
facility: Sacramento ENT
state: California
city: Boca Raton
country: United States
facility: ENT Associates of South Florida
state: Florida
city: Plantation
country: United States
facility: ENT Associates of South Florida
state: Florida
city: Chicago
country: United States
facility: Chicago Nasal and Sinus Center
state: Illinois
city: Baton Rouge
country: United States
facility: Baton Rouge General / Sinus and Nasal Specialists of Louisiana
state: Louisiana
city: Mount Arlington
country: United States
facility: Advocare Aroesty ENT Associates
state: New Jersey
city: Houston
country: United States
facility: UT Physicians Otorhinolaryngology - Texas Medical Center
state: Texas
city: McKinney
country: United States
facility: ENT Associates of Texas
state: Texas
Study officials:
References:
citation: Yao WC, Pritikin J, Sillers MJ, Barham HP. Two-year outcomes of temperature-controlled radiofrequency device treatment of the nasal valve for patients with nasal airway obstruction. Laryngoscope Investig Otolaryngol. 2023 Jun 15;8(4):808-815. doi: 10.1002/lio2.1089. eCollection 2023 Aug.
citation: Yao WC, Ow RA, Barham HP (2021) Temperature-Controlled Radiofrequency Treatment of the Nasal Valve and Nasal Airway Obstruction: Early Results of a Prospective, Multi-Center Study. J Otolaryngol Rhinol 7:104. doi.org/10.23937/2572-4193.1510105
citation: Yao WC, Ow R, Sillers MJ, Nachlas NE, Johnson CD, Ehmer D, Pritikin J, Barham HP. Three-Year Outcomes After Temperature-Controlled Radiofrequency Treatment of Nasal Airway Obstruction. OTO Open. 2025 Apr 7;9(2):e70111. doi: 10.1002/oto2.70111. eCollection 2025 Apr-Jun.