Nasal Airway ObstructionVATRACNCT04549545

Vivaer® Procedure for Treatment of Nasal Airway Obstruction Study

A study testing Vivaer ARC Stylus in people with Nasal Airway Obstruction, run by Aerin Medical at 12 sites in United States.

Completed

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

Official record

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Trial summary

The purpose of this study is to compare the Vivaer procedure with radiofrequency (RF) energy to sham procedure for treatment of nasal airway obstruction (NAO). Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Nasal Airway Obstruction
What is being tested?: Vivaer ARC Stylus
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 119 participants
Where: 12 sitesUnited States
Study dates: 12 Aug 2020to 4 Mar 2025
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 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 to 85 years (inclusively).
Willing and able to provide informed consent.
Willing and able to comply with the subject-specific requirements outlined in the Study Protocol.
Seeking treatment for nasal obstruction and willing to undergo an office-based procedure.
Baseline Nasal Obstruction Symptom Evaluation (NOSE) Scale score ≥ 55.
Nasal valve is a primary or significant contributor to the patient's nasal obstruction as determined by the study investigator (based on clinical presentation, physical examination, nasal endoscopy, etc.) and the patient has a positive response to any of the following temporary measures (based on patient history or office exam):

Show all 11Show fewer

Use of external nasal dilator strips (eg, Breathe Right Strips)
Use of internal nasal dilator cones
Modified Cottle Maneuver (manual elevation of the lateral nasal wall using a small instrument or cotton-tipped applicator to open the nasal valve)
Cottle Maneuver (manual lateral retraction of the cheek to open the nasal valve)
Dissatisfaction with medical management as judged by the patient. Defined as failed medical therapy (eg, decongestants, antihistamines, and/or nasal sprays for an appropriate period of time), but a positive response to internal or external nasal dilators.

Who cannot join

Prior surgery of the lateral nasal wall, including cephalic resection of the lower lateral cartilage, dome division or suture plication, alar graft or spreader graft placement.
Rhinoplasty, septoplasty, inferior turbinate reduction or functional endoscopic sinus surgery (FESS) within the preceding 3 months.
Severe case of any of the following: septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be the primary contributor to the patient's nasal obstruction symptoms and warranting surgical intervention.
Any adjunctive surgical nasal procedure planned on the same day or within 6 months after the Vivaer procedure.
Known or suspected to be pregnant or is lactating.
Participating in another clinical research study.
Other medical conditions which in the opinion of the investigator would predispose the patient to poor wound healing or increased surgical risk, or poor compliance with the requirements of the study.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

Bethlehem ENT
Bethlehem, Pennsylvania, 18017
ENT and Allergy Associates of Florida
Coral Springs, Florida, 33065
ENT Associates of South Florida
Fort Lauderdale, Florida, 33301
Advanced ENT and Allergy KY
Louisville, Kentucky, 40207
ENT Associates of Texas (ENTtex)
McKinney, Texas, 75070
Madison ENT
New York, New York, 10016
EVMS Ear Nose and Throat Surgeons
Norfolk, Virginia, 23507
Ogden Clinic
Ogden, Utah, 84403
ENT and Allergy Associates of Florida
Port Saint Lucie, Florida, 34952
Roseville Facial Plastic Surgery
Roseville, California, 95661
Breathe Clear Institute
Torrance, California, 90503
Piedmont ENT Associates NC
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: The Vivaer® Procedure for Treatment of Nasal Airway Obstruction - A ProspecTive, Multicenter Randomized Controlled TriAl Comparing Vivaer to Sham Control (VATRAC)

The purpose of this study is to compare the Vivaer procedure with radiofrequency (RF) energy to sham procedure for treatment of nasal airway obstruction (NAO).

Read the detailed description

The purpose of this study is to compare the Vivaer procedure for treatment of nasal airway obstruction (NAO) with a sham procedure that simulates the actual procedure as closely as possible absent the delivery of radiofrequency (RF) energy to the nasal tissue.

Conditions: Nasal Airway Obstruction
Being tested: Vivaer ARC Stylus, Sham
Keywords: Nasal obstruction, NAO, Nasal valve dysfunction, 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 ARC StylusDevice
The Vivaer procedure will be performed in the study clinic using the Vivaer ARC Stylus and Aerin Console. The Vivaer ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants in this study will undergo bilateral treatment of the nasal valves in a single study session.
ShamDevice
The sham control procedure will be performed in the study clinic using the Vivaer ARC Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s).

Study groups in NCT04549545
Study group	Role	What they receive
Vivaer Procedure	Active comparator	The Vivaer procedure will be performed in the study clinic using the Vivaer ARC Stylus and Aerin Console. The Vivaer ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants in this study will undergo bilateral treatment of the nasal valves in a single study session. Each side of the nose will be treated with up to four (4) non-overlapping applications of RF energy at the junction of the upper and lower lateral cartilage on the lateral nasal wall. Treatment settings to be used are: temperature 60° C, power 4 watts, treatment time 18 seconds, and cooling time 12 seconds. No repeat ("touch up") procedures will be permitted after the initial procedure through the end of the study (24 months). Receives: Device: Vivaer ARC Stylus
Sham Control Procedure	Sham comparator	The sham control procedure will be performed in the study clinic using the Vivaer ARC Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s). Receives: Device: Sham

What is being measured

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

Nasal Obstruction Symptom Evaluation (NOSE) Scale - 3 Month Responder Rate
The Nasal Obstruction Symptom Evaluation (NOSE) Scale is a patient self-reported questionnaire consisting of 5 symptoms of nasal obstruction: nasal congestion, nasal blockage, trouble breathing, trouble sleeping, and getting enough air during exercise. Patients will report over the past 1 month how much the symptoms have been a problem. Total score ranges from 0 to 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as mild (range, 5-25), moderate (range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses.
Measured: 3 months visit following the study procedure.

Secondary outcomes (2)

Nasal Obstruction Symptom Evaluation (NOSE) Scale Mean Change From Baseline Through 3 Months
The NOSE Scale is a patient self-reported questionnaire consisting of 5 symptoms of nasal obstruction: nasal congestion, nasal blockage, trouble breathing, trouble sleeping, and getting enough air during exercise. Patients will report over the past 1 month how much the symptoms have been a problem. Total score ranges from 0 to 100, where higher scores indicate worse obstruction.
This study will measure the mean change in NOSE Scale from baseline to 3 months after procedure.
Measured: Change from Baseline to 3 months following the study procedure.
Percentage of Participants With Treatment Related Events (Safety) - Through 3 Months
Characterizing the type and frequency of adverse events reported. Subjects will be asked about possible side effects or adverse experiences related to the study procedure at each follow up visit. All events will be documented and identified as to its relationship and level of relatedness to the study device and/or study procedure. Date of onset, seriousness, intensity, duration and outcome will be documented.
Measured: At or following the study procedure up to to 3 months.

Timeline

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

12 Aug 20204 Mar 2025

First posted16 Sep 2020
Study start12 Aug 2020
Primary completion10 Mar 2021
Study completion4 Mar 2025

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 (4)Papers the sponsor has linked to this study.
Other trials for Nasal Airway 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: Randomised
Intervention model: Crossover
Model description: 2:1 site-stratified randomization will be used to allocate participants to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure). Crossover within 30 days after 3 month follow-up visit.
Masking: Single blind
Who is masked: Participant
Enrolment: 119 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04549545
Sponsor's protocol ID: CTP1006
Acronym: VATRAC
Status last verified: Oct 2026
First submitted: 9 Sep 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

Silvers SL, Rosenthal JN, McDuffie CM, Yen DM, Han JK. Temperature-controlled radiofrequency device treatment of the nasal valve for nasal airway obstruction: A randomized controlled trial. Int Forum Allergy Rhinol. 2021 Dec;11(12):1676-1684. doi: 10.1002/alr.22861. Epub 2021 Jul 9.
PubMed 34240571
Han JK, Silvers SL, Rosenthal JN, McDuffie CM, Yen DM. Outcomes 12 Months After Temperature-Controlled Radiofrequency Device Treatment of the Nasal Valve for Patients With Nasal Airway Obstruction. JAMA Otolaryngol Head Neck Surg. 2022 Oct 1;148(10):940-946. doi: 10.1001/jamaoto.2022.2293.
PubMed 36048465
Silvers SL, McDuffie CM, Yen DM, Rosenthal JN, Davis SE, Han JK. Two-year outcomes of radiofrequency device treatment of the nasal valve for nasal airway obstruction. Rhinology. 2024 Jun 1;62(3):310-319. doi: 10.4193/RhinRhin23.377.
PubMed 38217847
Han JK, Rosenthal JN, McDuffie CM, Yen DM, Bikhazi NB, Kakarlapudi VV, Silvers SL. Temperature-Controlled Radiofrequency Treatment of the Nasal Valve in Patients With Nasal Obstruction: Long-Term Outcomes. Otolaryngol Head Neck Surg. 2025 Apr;172(4):1214-1223. doi: 10.1002/ohn.1118. Epub 2025 Jan 17.
PubMed 39822054

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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Active, not recruitingObservational study
A Prospective Study Comparing VivAer to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction.
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Measuring Nasal Airway Changes After VivAer Treatment Using AI Analysis
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All Nasal Airway 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: The Vivaer® Procedure for Treatment of Nasal Airway Obstruction - A ProspecTive, Multicenter Randomized Controlled TriAl Comparing Vivaer to Sham Control (VATRAC)
ClinicalTrials.gov ID: NCT04549545
Acronym / sponsor ID: VATRAC / CTP1006
Conditions: Nasal Airway Obstruction
Keywords: Nasal obstruction, NAO, Nasal valve dysfunction, Nasal airway obstruction
Study type: Interventional
Recruitment status: Completed
Enrolment: 119 participants (actual)
Lead sponsor: Aerin MedicalIndustry (pharma, biotech, devices)
Study start: 12 Aug 2020 (actual)
Primary completion: 10 Mar 2021 (actual)
Study completion: 4 Mar 2025 (actual)
First posted: 16 Sep 2020 (actual)
Results: Posted 12 Jun 2024

Clinical summary

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

The purpose of this study is to compare the Vivaer procedure with radiofrequency (RF) energy to sham procedure for treatment of nasal airway obstruction (NAO).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2
Model description: 2:1 site-stratified randomization will be used to allocate participants to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure). Crossover within 30 days after 3 month follow-up visit.

Arm	Type	Receives
Vivaer Procedure	Active comparator	Device: Vivaer ARC StylusThe Vivaer procedure will be performed in the study clinic using the Vivaer ARC Stylus and Aerin Console. The Vivaer ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants in this study will undergo bilateral treatment of the nasal valves in a single study session. Each side of the nose will be treated with up to four (4) non-overlapping applications of RF energy at the junction of the upper and lower lateral cartilage on the lateral nasal wall. Treatment settings to be used are: temperature 60° C, power 4 watts, treatment time 18 seconds, and cooling time 12 seconds. No repeat ("touch up") procedures will be permitted after the initial procedure through the end of the study (24 months).
Sham Control Procedure	Sham comparator	Device: ShamThe sham control procedure will be performed in the study clinic using the Vivaer ARC Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s).

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Age 18 to 85 years (inclusively).
Willing and able to provide informed consent.
Willing and able to comply with the subject-specific requirements outlined in the Study Protocol.
Seeking treatment for nasal obstruction and willing to undergo an office-based procedure.
Baseline Nasal Obstruction Symptom Evaluation (NOSE) Scale score ≥ 55.

Key exclusion criteria (7 listed)

Prior surgery of the lateral nasal wall, including cephalic resection of the lower lateral cartilage, dome division or suture plication, alar graft or spreader graft placement.
Rhinoplasty, septoplasty, inferior turbinate reduction or functional endoscopic sinus surgery (FESS) within the preceding 3 months.
Severe case of any of the following: septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be the primary contributor to the patient's nasal obstruction symptoms and warranting surgical intervention.
Any adjunctive surgical nasal procedure planned on the same day or within 6 months after the Vivaer procedure.
Known or suspected to be pregnant or is lactating.

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 ARC StylusThe Vivaer procedure will be performed in the study clinic using the Vivaer ARC Stylus and Aerin Console. The Vivaer ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants in this study will undergo bilateral treatment of the nasal valves in a single study session.	Device	Vivaer Procedure
ShamThe sham control procedure will be performed in the study clinic using the Vivaer ARC Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s).	Device	Sham Control Procedure

Primary outcome

Nasal Obstruction Symptom Evaluation (NOSE) Scale - 3 Month Responder Rate
Time frame: 3 months visit following the study procedure.
The Nasal Obstruction Symptom Evaluation (NOSE) Scale is a patient self-reported questionnaire consisting of 5 symptoms of nasal obstruction: nasal congestion, nasal blockage, trouble breathing, trouble sleeping, and getting enough air during exercise. Patients will report over the past 1 month how much the symptoms have been a problem. Total score ranges from 0 to 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as mild (range, 5-25), moderate (range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses.

2 secondary outcomes

Nasal Obstruction Symptom Evaluation (NOSE) Scale Mean Change From Baseline Through 3 Months
Time frame: Change from Baseline to 3 months following the study procedure.
Percentage of Participants With Treatment Related Events (Safety) - Through 3 Months
Time frame: At or following the study procedure up to to 3 months.

Results and safety

Results posted to the registry on 12 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Treatment Arm: Vivaer Procedure Only	78	68
Control Arm: Sham Control Procedure First, Optional Crossover to Vivaer Procedure	41	31

Primary outcome: Nasal Obstruction Symptom Evaluation (NOSE) Scale - 3 Month Responder Rate

Time frame: 3 months visit following the study procedure.. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Active Treatment Arm: Vivaer Procedure n = 77	Control Arm: Sham Control Procedure n = 39
Value	88.3 (79.2 to 93.7)	42.5 (28.5 to 57.8)

Population analysed: The percentage of patients designated responders, defined as 20% or greater improvement (decrease) in Nasal Obstruction Symptom Evaluation (NOSE)Scale score or 1 or greater NOSE Scale severity category improvement from baseline. Error bars indicate 95% CIs.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vivaer Procedure	0 of 108 (0%)	7 of 108 (6.5%)	0 of 108
Sham Control Procedure	0 of 39 (0%)	1 of 39 (2.6%)	0 of 39

Limitations and caveats (from the sponsor): Medication use was not dictated by the protocol and could affect symptom relief; Data presented are through 12 months and continued follow-up will provide additional data on long term durability. Only subjects with nasal valve collapse as primary NAO were enrolled, but some subjects may have other contributors - for this reason, eligibility exclusion criteria should be considered with results.

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 34240571Silvers SL, Rosenthal JN, McDuffie CM, Yen DM, Han JK. Temperature-controlled radiofrequency device treatment of the nasal valve for nasal airway obstruction: A randomized controlled trial. Int Forum Allergy Rhinol. 2021 Dec;11(12):1676-1684. doi: 10.1002/alr.22861. Epub 2021 Jul 9.
Results publication: PubMed 36048465Han JK, Silvers SL, Rosenthal JN, McDuffie CM, Yen DM. Outcomes 12 Months After Temperature-Controlled Radiofrequency Device Treatment of the Nasal Valve for Patients With Nasal Airway Obstruction. JAMA Otolaryngol Head Neck Surg. 2022 Oct 1;148(10):940-946. doi: 10.1001/jamaoto.2022.2293.
Results publication: PubMed 38217847Silvers SL, McDuffie CM, Yen DM, Rosenthal JN, Davis SE, Han JK. Two-year outcomes of radiofrequency device treatment of the nasal valve for nasal airway obstruction. Rhinology. 2024 Jun 1;62(3):310-319. doi: 10.4193/RhinRhin23.377.
Results publication: PubMed 39822054Han JK, Rosenthal JN, McDuffie CM, Yen DM, Bikhazi NB, Kakarlapudi VV, Silvers SL. Temperature-Controlled Radiofrequency Treatment of the Nasal Valve in Patients With Nasal Obstruction: Long-Term Outcomes. Otolaryngol Head Neck Surg. 2025 Apr;172(4):1214-1223. doi: 10.1002/ohn.1118. Epub 2025 Jan 17.
Individual participant dataSharing planned: No

Related trials for Nasal Airway 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
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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
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Post-Market Clinical Study to Evaluate the Safety and Effectiveness of REFLEX ULTRA 45 for Coblation Inferior Turbinate Reduction in China
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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.

Joseph Han, MD principal investigator

EVMS Medical Group

Stacey Silvers, MD principal investigator

Madison ENT

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

Questions about this trial

What is this clinical trial studying?

A study testing Vivaer ARC Stylus in people with Nasal Airway Obstruction, run by Aerin Medical at 12 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 11 inclusion and 7 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 12 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. Some participants in this study may receive a placebo. 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 12 Jun 2024). 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?

Nasal Obstruction Symptom Evaluation (NOSE) Scale - 3 Month Responder Rate (time frame: 3 months visit following the study procedure.). 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 NCT04549545, which also lists 4 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.