Nasal ObstructionAERWAYNCT04277507

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

A study testing Vivaer Stylus in people with Nasal Obstruction, run by Aerin Medical at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Nasal Obstruction
What is being tested?: Vivaer Stylus
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 122 participants
Where: 10 sitesUnited States
Study dates: 7 Feb 2020to 11 Oct 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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):

Show all 10Show fewer

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)

Who cannot join

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.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Baton Rouge General / Sinus and Nasal Specialists of Louisiana
Baton Rouge, Louisiana, 70809
Alabama Nasal and Sinus Center
Birmingham, Alabama, 35242
ENT Associates of South Florida
Boca Raton, Florida, 33487
Chicago Nasal and Sinus Center
Chicago, Illinois, 60602
Arizona Desert ENT Specialists
Goodyear, Arizona, 85395
UT Physicians Otorhinolaryngology - Texas Medical Center
Houston, Texas, 77030
ENT Associates of Texas
McKinney, Texas, 75070
Advocare Aroesty ENT Associates
Mount Arlington, New Jersey, 07856
ENT Associates of South Florida
Plantation, Florida, 33324
Sacramento ENT
Roseville, California, 95661

Other trials in United States

About this study

Official title: A Prospective, Multicenter Study of the AERin Medical Vivaer® ARC Stylus for Nasal AirWAY Obstruction (AERWAY)

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

Read the 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.

Conditions: Nasal Obstruction
Being tested: Vivaer Stylus
Keywords: Nasal valve, Nasal airway obstruction
Medical subject headings: Nasal Obstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vivaer StylusDevice
Also called Aerin Medical Device
Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area

Study groups in NCT04277507
Study group	Role	What they receive
Vivaer Stylus	Experimental	Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area Receives: Device: Vivaer Stylus

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 3 Month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Feb 202011 Oct 2024

First posted20 Feb 2020
Study start7 Feb 2020
Primary completion31 Dec 2020
Study completion11 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Nasal ObstructionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 122 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04277507
Sponsor's protocol ID: TP900
Acronym: AERWAY
Status last verified: Oct 2026
First submitted: 17 Feb 2020
Last updated: 2 Nov 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 37621275
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
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.
PubMed 40196218

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
Recruiting
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
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Active, not recruitingObservational study
A Prospective Study Comparing VivAer to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction.
Nasal Airway Obstruction
Recruiting
Measuring Nasal Airway Changes After VivAer Treatment Using AI Analysis
Nasal Airway Obstruction
Recruiting
Post-Market Clinical Study to Evaluate the Safety and Effectiveness of REFLEX ULTRA 45 for Coblation Inferior Turbinate Reduction in China
Nasal Obstruction Due to Inferior Turbinate Hypertrophy

All Nasal Obstruction trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multicenter Study of the AERin Medical Vivaer® ARC Stylus for Nasal AirWAY Obstruction (AERWAY)
ClinicalTrials.gov ID: NCT04277507
Acronym / sponsor ID: AERWAY / TP900
Conditions: Nasal Obstruction
Keywords: Nasal valve, Nasal airway obstruction
Study type: Interventional
Recruitment status: Completed
Enrolment: 122 participants (actual)
Lead sponsor: Aerin MedicalIndustry (pharma, biotech, devices)
Study start: 7 Feb 2020 (actual)
Primary completion: 31 Dec 2020 (actual)
Study completion: 11 Oct 2024 (actual)
First posted: 20 Feb 2020 (actual)
Results: Posted 25 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Vivaer Stylus	Experimental	Device: Vivaer StylusIntervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vivaer StylusAlso: Aerin Medical DeviceDelivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area	Device	Vivaer Stylus

Primary outcome

Change in Nasal Obstructive Symptom Evaluation (NOSE) Scores From Baseline to 3 Months
Time frame: 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.

Results and safety

Results posted to the registry on 25 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vivaer Treatment	122	91

Primary outcome: Change in Nasal Obstructive Symptom Evaluation (NOSE) Scores From Baseline to 3 Months

Time frame: 3 Month. Mean (Standard Error). Unit: score on a scale

Measure	Protocol Eligible Subjects n = 119
Value	-47.6 (26.1)

Adverse events

Time frame: 2 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vivaer Treatment	1 of 122 (0.8%)	0 of 122 (0%)	1 of 122

Limitations and caveats (from the sponsor): Limitations of this study are its lack of a control arm and the non-blinded nature of this study

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 37621275Yao 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.
Results publicationYao 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
Results publication: PubMed 40196218Yao 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.
Individual participant dataSharing planned: No

Related trials for Nasal Obstruction

Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
Recruiting
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
Postoperative Sore Throat, Nasal Obstruction
Active, not recruitingObservational study
A Prospective Study Comparing VivAer to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction.
Nasal Airway Obstruction
Recruiting
Measuring Nasal Airway Changes After VivAer Treatment Using AI Analysis
Nasal Airway Obstruction
Recruiting
Post-Market Clinical Study to Evaluate the Safety and Effectiveness of REFLEX ULTRA 45 for Coblation Inferior Turbinate Reduction in China
Nasal Obstruction Due to Inferior Turbinate Hypertrophy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Vivaer Stylus in people with Nasal Obstruction, run by Aerin Medical at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Nasal Obstructive Symptom Evaluation (NOSE) Scores From Baseline to 3 Months (time frame: 3 Month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04277507, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.