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

Not Applicable

Completed

• Conditions: Nasal Obstruction
• Interventions: Device: Vivaer Stylus

• Registration Number: NCT04277507
• Lead Sponsor: Aerin Medical

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.

Study Timeline

• Study Start: 2020-02-07
• Study First Submitted: 2020-02-17
• Study First Submitted QC: 2020-02-18
• Study First Posted: 2020-02-20
• Primary Completion: 2020-12-31
• Results First Submitted: 2023-01-30
• Results First Submitted QC: 2023-05-02
• Results First Posted: 2023-05-25
• Study Completion: 2024-10-11
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vivaer Stylus	Vivaer Stylus	Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area

Primary Outcome Measures

Name	Time	Method
Change in Nasal Obstructive Symptom Evaluation (NOSE) Scores From Baseline to 3 Months	3 Month	Mean change in NOSE score from Baseline to 3 months.Scores may range from the best score of 0, meaning no nasal obstructive symptoms to the worst score of 100, meaning severe nasal obstructive symptoms.

Trial Locations

Locations (9)

Sacramento ENT; 🇺🇸 Roseville, California, United States

ENT Associates of Texas; 🇺🇸 McKinney, Texas, United States

ENT Associates of South Florida; 🇺🇸 Plantation, Florida, United States

Arizona Desert ENT Specialists; 🇺🇸 Goodyear, Arizona, United States

Baton Rouge General / Sinus and Nasal Specialists of Louisiana; 🇺🇸 Baton Rouge, Louisiana, United States

Advocare Aroesty ENT Associates; 🇺🇸 Mount Arlington, New Jersey, United States

Alabama Nasal and Sinus Center; 🇺🇸 Birmingham, Alabama, United States

Chicago Nasal and Sinus Center; 🇺🇸 Chicago, Illinois, United States

UT Physicians Otorhinolaryngology - Texas Medical Center; 🇺🇸 Houston, Texas, United States