Nasal Airway ObstructionCompAerNCT06922955
A Prospective Study Comparing VivAer to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction.
An observational study of Nasal Airway Obstruction, run by Aerin Medical at 35 sites in United States.
Trial summary
The purpose of this study is to compare the clinical outcomes of the VivAer procedure to functional rhinoplasty and septoplasty surgery for the treatment of nasal airway obstruction (NAO) to establish non-inferiority. Read more about this study
- Who is it for?
- Ages 22 to 85 years
- Conditions the study is for
- Nasal Airway Obstruction
- How many people
- 400 participants
- Where
- 35 sitesUnited States
- Study dates
- 28 Feb 2025to Dec 2027
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 22 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients between the ages of 22-85 seeking treatments for nasal airway obstruction.
Who may be able to join
- Age 22 to 85 years old (inclusively).
- Willing and able to provide consent.
- Willing and able to comply with the patient-specific requirements outlined in the study protocol.
- Has access to a mobile device, tablet, or computer with internet access and has access to an email address.
- Seeking treatment for NAO
- Has a NOSE Score of ≥55 indicating severe to extreme NAO.
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- Have a positive modified Cottle maneuver.
- Planning either to undergo an intervention for NAO that includes one of the following as the primary approach:
- VivAer procedure for repair of nasal valve dysfunction (may include inferior turbinate and septal swell body as additional treated areas)
- Functional rhinoplasty surgery addressing the nasal valve and/or lateral nasal wall (may be combined with septoplasty with/without turbinoplasty performed alone or in combination).
- Septoplasty surgery with turbinate reduction.
Who cannot join
- Has had nasal surgery (including sinus surgery) within the last 3 months.
- Has had a previous rhinoplasty (functional or cosmetic), septoplasty, inferior turbinate reduction, or VivAer procedure.
- Has extreme nasal pathology, a history of extreme nasal injuries, or an abnormal nasal condition (e.g. septal perforation or empty nose syndrome) that may be exacerbated by surgery.
- Has a medical condition(s) that may impair normal healing processes or be exacerbated by the stress of surgery.
- Has chronic rhinitis that is refractory to medications or rhinitis medicamentosa.
- Has poorly controlled chronic rhinosinusitis disease.
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- Rhinoplasty is being performed primarily for cosmesis.
- Is receiving, planning to receive, or has received a Latera absorbable nasal implant at any time.
- Planning to have sinus or cosmetic surgery (e.g., functional endoscopic sinus surgery, cosmetic rhinoplasty) or a surgery involving the airway (e.g., hypoglossal nerve stimulation surgery, uvuloplasty, tonsillectomy, tongue base or soft palate interventions) within 6 months following enrollment.
- Is having an adjunctive surgical procedure performed with the primary NAO procedure (e.g. functional rhinoplasty with concha bullosa reduction, septoplasty with turbinate reduction performed with functional endoscopic sinus surgery)
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Southern Head and Neck Surgery
Alexander City, Alabama, 35010
Bethlehem ENT /Specialty Physician Associates
Bethlehem, Pennsylvania, 18017
ExcelENT
Birmingham, Alabama, 35244
ENT & Allergy Associates of Florida (Boynton Beach)
Boynton Beach, Florida, 33472
University of Virginia
Charlottesville, Virginia, 22908
Chicago Nasal and Sinus Center
Chicago, Illinois, 60602
Chicago ENT
Chicago, Illinois, 60657
Dearborn ENT
Dearborn, Michigan, 48124
IMMUNOe Research Center
Denver, Colorado, 80249
Advanced ENT and Allergy
Fernandina Beach, Florida, 32034
Arizona Desert ENT Specialists
Goodyear, Arizona, 85395
North Alabama ENT
Huntsville, Alabama, 35801
Dearborn ENT Livonia
Livonia, Michigan, 48154
Cedars Sinai Medical Center
Los Angeles, California, 90048
Kentuckia Ear Nose & Throat
Louisville, Kentucky, 40205
ENT Associates of Texas
McKinney, Texas, 75070
Hill Country ENT
New Braunfels, Texas, 78130
Maddison ENT
New York, New York, 10016
Madison ENT
New York, New York, 10016
Open Sinus
New York, New York, 10019
Alexis Furze, MD Inc
Newport Beach, California, 92663
East Alabama ENT
Opelika, Alabama, 36801
ENT and Allergy Associates of Florida
Plantation, Florida, 33324
ENT and Allergy Associates Of Florida
Port Saint Lucie, Florida, 34952
ENT & Allergy Associates
Puyallup, Washington, 98373
University of Rochester
Rochester, New York, 14627
Sacramento ENT (DaVinci Research)
Roseville, California, 95661
Mercy Medical Group
Sacramento, California, 95816
Endormir Sleep Solution LLC
San Antonio, Texas, 78230
Texas Facial Plastic Surgery & ENT
San Antonio, Texas, 78230
Alamo ENT Associates
San Antonio, Texas, 78258
Honor Health ENT
Scottsdale, Arizona, 85255
Breathe Clear Institute
Torrance, California, 90503
Tucson ENT
Tucson, Arizona, 85704
ENT and Allergy Associates of Florida (West Palm Beach)
West Palm Beach, Florida, 33407
About this study
Official title: A Prospective, Open-label, Multi-center, Non-inferiority Study Comparing VivAer® to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction (The CompAer Study).
The purpose of this study is to compare the clinical outcomes of the VivAer procedure to functional rhinoplasty and septoplasty surgery for the treatment of nasal airway obstruction (NAO) to establish non-inferiority.
Read the detailed description
The purpose of this study is to compare the clinical outcomes of the VivAer procedure to functional rhinoplasty and septoplasty surgery for the treatment of nasal airway obstruction (NAO) to establish non-inferiority by using the NOSE scale to evaluate the significance of a patient's nasal obstruction both before and after the procedure for the primary endpoint.
- Conditions
- Nasal Airway Obstruction
- Keywords
- NAO, Nasal Airway Obstruction, Nasal, Nasal Airway, CompAer, VivAer, nasal valve dysfunction, NOSE
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| VivAer Arm | The VivAer treatment arm will be comprised of patients undergoing the minimally invasive VivAer procedure using the VivAer Stylus and Aerin Console. The VivAer Stylus is a disposable handheld device capable of delivering bipolar radiofrequency (RF) energy to tissue when connected to the Aerin Console radiofrequency generating device. Treatments will be performed using the VivAer Stylus and Aerin Console using non-overlapping and device default settings (temperature 60° C, power 4 watts, treatment time 18 seconds, and cooling time 12 seconds). VivAer treatment areas will include at minimum the lateral nasal wall in the area of the upper lateral cartilage and may also involve treatment of the inferior turbinate and/or septal swell body at the discretion of the investigator according to individual patient needs. | |
| Surgical Comparator Arm | The two surgical intervention arms will be comprised of patients undergoing surgical intervention for the treatment of NAO as follows: * Functional Rhinoplasty Arm: This arm will include patients undergoing primary functional rhinoplasty surgery for NAO addressing the nasal valve and/or lateral nasal wall and may be performed with septoplasty or turbinoplasty performed alone or in combination). This procedure may include minor aspects of cosmesis (e.g., dorsal hump reduction) at the discretion of the investigator. * Septoplasty arm: This arm will include patients undergoing a septoplasty with or without turbinate reduction as the only procedures performed for NAO. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal Obstruction Symptom Evaluation (NOSE) Scale
To evaluate the significance of a patient's nasal obstruction both before and after the procedure for the primary endpoint, this study will use the well-known subjective patient-reported outcome measure, the NOSE Scale. The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure outcomes of participants treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale with a total score range of 0 through 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 to the NOSE survey.
Individual participant success (treatment responder) is based on NOSE Scale improvement defined as a ≥ 24 point improvement (decrease) in NOSE Scale score from baseline to the 3-month evaluation.
Measured: 3 months, 6 months, 12 months and 24 months post-procedure.
Secondary outcomes (6)
Epworth Sleepiness Scale (ESS)
The ESS evaluates the self-reported likelihood of dozing or falling asleep in 8 daytime situations with likelihood rated as No Chance (0), Slight (1), Moderate (2), or High Chance (3).
Measured: 3 months, 6 months, 12 months and 24 months post-procedure.
12-item Short Form (SF-12) Survey
The SF-12 is one of the most widely used instruments for assessing self-reported health-related quality of life, and has been validated in numerous studies.40 The SF-12 is a general health questionnaire that consists of 12 questions which investigates the patient's perception about their state of health via 8 different dimensions: General health perception - 1 question, Physical health - 2 questions, Limited physical role function - 2 questions, Physical pain - 1 question, Vitality - 1 question, Mental health - 2 questions, Limited emotional role function - 2 questions, and Social functioning - 1 question. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. A score above 50 indicates better than average health-related quality of life and scores less than 50 suggest below-average health.41
Measured: 3 months, 6 months, 12 months and 24 months post-procedure.
Visual Analogy Scale (VAS) Score
The Visual Analogue Scale (VAS) is a unidimensional measure of pain intensity that will be used to measure nasal pain associated with the procedure.39 A VAS is usually a 100-mm long horizontal line with verbal descriptors (word anchors) at each end to express the extremes of the feeling. Scores are obtained by measuring the distance in millimeters from the left origin of the line (0) to the point indicated with a slash placed by the patient to indicate their current level of pain in and around the nose. Results are then assigned a score between 0 and 100.
Measured: 1 week post procedure
Return to Work
Assessment of the number of workdays missed within the first month due to the receiving the procedure will be collected.
Measured: 3 months post procedure.
Patient Satisfaction with Procedure
Satisfaction with the procedure is measured with a five-question, self-reported survey using a 5-point scale to assess tolerability of the procedure, ease of recovery, change in NAO symptoms, overall satisfaction with the procedure, and recommendation to others.
Measured: 3 months, 6 months, 12 months and 24 months post-procedure.
Adverse Events
Physician and patient reported adverse events will be collected.
Measured: Through study completion, minimum 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start28 Feb 2025
- Primary completionJun 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Aerin Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922955
- Sponsor's protocol ID
- CTP1563
- Acronym
- CompAer
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Davis G, Aziz Z, Barrera J, Blythe W, Davis C, Davis S, Higgins T, Lano C, Levitin G, Lopatin F, Oyer S, Silvers S, Waitzman A, Ow R. Temperature-Controlled Radiofrequency for Severe Nasal Airway Obstruction: A Non-Inferiority Comparison With Surgical Intervention. Int Forum Allergy Rhinol. 2026 Apr 14. doi: 10.1002/alr.70165. Online ahead of print.
PubMed 41979070
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Multi-center, Non-inferiority Study Comparing VivAer® to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction (The CompAer Study).
- ClinicalTrials.gov ID
- NCT06922955
- Acronym / sponsor ID
- CompAer / CTP1563
- Conditions
- Nasal Airway Obstruction
- Keywords
- NAO, Nasal Airway Obstruction, Nasal, Nasal Airway, CompAer, VivAer, nasal valve dysfunction, NOSE
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Aerin MedicalIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
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 clinical outcomes of the VivAer procedure to functional rhinoplasty and septoplasty surgery for the treatment of nasal airway obstruction (NAO) to establish non-inferiority.
Detailed description
The purpose of this study is to compare the clinical outcomes of the VivAer procedure to functional rhinoplasty and septoplasty surgery for the treatment of nasal airway obstruction (NAO) to establish non-inferiority by using the NOSE scale to evaluate the significance of a patient's nasal obstruction both before and after the procedure for the primary endpoint.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VivAer Arm | – | –The VivAer treatment arm will be comprised of patients undergoing the minimally invasive VivAer procedure using the VivAer Stylus and Aerin Console. The VivAer Stylus is a disposable handheld device capable of delivering bipolar radiofrequency (RF) energy to tissue when connected to the Aerin Console radiofrequency generating device. Treatments will be performed using the VivAer Stylus and Aerin Console using non-overlapping and device default settings (temperature 60° C, power 4 watts, treatment time 18 seconds, and cooling time 12 seconds). VivAer treatment areas will include at minimum the lateral nasal wall in the area of the upper lateral cartilage and may also involve treatment of the inferior turbinate and/or septal swell body at the discretion of the investigator according to individual patient needs. |
| Surgical Comparator Arm | – | –The two surgical intervention arms will be comprised of patients undergoing surgical intervention for the treatment of NAO as follows: * Functional Rhinoplasty Arm: This arm will include patients undergoing primary functional rhinoplasty surgery for NAO addressing the nasal valve and/or lateral nasal wall and may be performed with septoplasty or turbinoplasty performed alone or in combination). This procedure may include minor aspects of cosmesis (e.g., dorsal hump reduction) at the discretion of the investigator. * Septoplasty arm: This arm will include patients undergoing a septoplasty with or without turbinate reduction as the only procedures performed for NAO. |
Who may qualify
- Ages
- 22 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients between the ages of 22-85 seeking treatments for nasal airway obstruction.
Key inclusion criteria (11 listed)
- Age 22 to 85 years old (inclusively).
- Willing and able to provide consent.
- Willing and able to comply with the patient-specific requirements outlined in the study protocol.
- Has access to a mobile device, tablet, or computer with internet access and has access to an email address.
- Seeking treatment for NAO
Key exclusion criteria (10 listed)
- Has had nasal surgery (including sinus surgery) within the last 3 months.
- Has had a previous rhinoplasty (functional or cosmetic), septoplasty, inferior turbinate reduction, or VivAer procedure.
- Has extreme nasal pathology, a history of extreme nasal injuries, or an abnormal nasal condition (e.g. septal perforation or empty nose syndrome) that may be exacerbated by surgery.
- Has a medical condition(s) that may impair normal healing processes or be exacerbated by the stress of surgery.
- Has chronic rhinitis that is refractory to medications or rhinitis medicamentosa.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nasal Obstruction Symptom Evaluation (NOSE) Scale
Time frame: 3 months, 6 months, 12 months and 24 months post-procedure.
To evaluate the significance of a patient's nasal obstruction both before and after the procedure for the primary endpoint, this study will use the well-known subjective patient-reported outcome measure, the NOSE Scale. The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure outcomes of participants treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale with a total score range of 0 through 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 to the NOSE survey. Individual participant success (treatment responder) is based on NOSE Scale improvement defined as a ≥ 24 point improvement (decrease) in NOSE Scale score from baseline to the 3-month evaluation.
6 secondary outcomes
Epworth Sleepiness Scale (ESS)
Time frame: 3 months, 6 months, 12 months and 24 months post-procedure.
12-item Short Form (SF-12) Survey
Time frame: 3 months, 6 months, 12 months and 24 months post-procedure.
Visual Analogy Scale (VAS) Score
Time frame: 1 week post procedure
Return to Work
Time frame: 3 months post procedure.
Patient Satisfaction with Procedure
Time frame: 3 months, 6 months, 12 months and 24 months post-procedure.
Adverse Events
Time frame: Through study completion, minimum 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Derived from this study: PubMed 41979070Davis G, Aziz Z, Barrera J, Blythe W, Davis C, Davis S, Higgins T, Lano C, Levitin G, Lopatin F, Oyer S, Silvers S, Waitzman A, Ow R. Temperature-Controlled Radiofrequency for Severe Nasal Airway Obstruction: A Non-Inferiority Comparison With Surgical Intervention. Int Forum Allergy Rhinol. 2026 Apr 14. doi: 10.1002/alr.70165. Online ahead of print.
- Individual participant dataSharing planned: No
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Performance and Safety Assessment of the Mechanical Decongestant Seawater Spray Enriched With Essential Oils From Laboratoires Gilbert in Patient With Acute Rhinitis Associated With Nasal Obstruction
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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.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasal Airway Obstruction, run by Aerin Medical at 35 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 10 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: under way, not looking for participants, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 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?
This study is still under way. Results are not available in the source record yet.
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 (time frame: 3 months, 6 months, 12 months and 24 months post-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 NCT06922955, which also lists 1 linked publication.
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 23 Mar 2026.