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

NCT04277507 | Completed Results FDA Device

• 1 other identifier: TP900
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Nasal Obstruction

Keywords

Nasal valve; Nasal airway obstruction

Outcome Measures

Primary Outcomes (1)

• Change in Nasal Obstructive Symptom Evaluation (NOSE) Scores From Baseline to 3 Months

  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.

  3 Month

Other Outcomes (3)

• Subject-reported Visual Analog Scale (VAS) Pain Scores in Relation to the Area Treated by the Study Procedure

  3 months post study procedure

• Subject Reported Change in Medication Use for Nasal Obstruction Symptoms

  24 Month

• Change in Nasal Obstructive Symptom Evaluation (NOSE)Scores From Baseline to 24 Months - Analysis

  24 Months

Study Arms (1)

Vivaer Stylus

EXPERIMENTAL

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

Device: Vivaer Stylus

Interventions

Vivaer Stylus DEVICE

Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area

Also known as: Aerin Medical Device

Vivaer Stylus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aerin Medical: lead

Study Sites (10)

Alabama Nasal and Sinus Center

Birmingham, Alabama, 35242, United States

Location

Arizona Desert ENT Specialists

Goodyear, Arizona, 85395, United States

Location

Sacramento ENT

Roseville, California, 95661, United States

Location

ENT Associates of South Florida

Boca Raton, Florida, 33487, United States

Location

ENT Associates of South Florida

Plantation, Florida, 33324, United States

Location

Chicago Nasal and Sinus Center

Chicago, Illinois, 60602, United States

Location

Baton Rouge General / Sinus and Nasal Specialists of Louisiana

Baton Rouge, Louisiana, 70809, United States

Location

Advocare Aroesty ENT Associates

Mount Arlington, New Jersey, 07856, United States

Location

UT Physicians Otorhinolaryngology - Texas Medical Center

Houston, Texas, 77030, United States

Location

ENT Associates of Texas

McKinney, Texas, 75070, United States

Location

Related Publications (3)

• 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.

  PMID: 37621275 RESULT

• 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

  RESULT

• 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.

  PMID: 40196218 RESULT

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Limitations and Caveats

Limitations of this study are its lack of a control arm and the non-blinded nature of this study

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: Aerin Medical

alaborde@aerinmedical.com

650-518-9624

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 20, 2020
• Study Start: February 7, 2020
• Primary Completion: December 31, 2020
• Study Completion: October 11, 2024
• Last Updated: May 4, 2025
• Results First Posted: May 25, 2023

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)