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RecruitingNCT07574918BREATHE AIUpdated Oct 30, 2026

Measuring Nasal Airway Changes After VivAer Treatment Using AI Analysis

An interventional study of VivAer Stylus in Nasal Airway Obstruction, sponsored by Aerin Medical. Recruiting at 1 site in United States. Open to participants aged 22 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Aerin Medical · Not applicable, Interventional, and Treatment

Updated Oct 30, 2026Now RecruitingFirst site in United States+5 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
22 Years to 85 Years
Sex
All
01

Study summary

The goal of this clinical trial is to measure changes in the nasal airway after treatment with the VivAer® procedure in adults aged 22 to 85 with nasal airway obstruction caused by nasal valve dysfunction. The main questions it aims to answer are:

Are there measurable changes in the nasal airway and airflow after treatment with the VivAer procedure?

Participants will:

Undergo the VivAer procedure, which uses radiofrequency energy to remodel tissue in the nasal valve area. Have endoscopic images of their nasal airway taken before treatment and at follow-up visits at 3 and 6 months after treatment, which will be analyzed using the VISIONAIR™ AI System. They will complete symptom and quality of life surveys at each visit, including the Nasal Obstruction Symptom Evaluation (NOSE) Scale, the STOP-BANG Sleep Score, and the Short-Form (SF-12) Health Survey.

02

Conditions studied

  • Nasal Airway Obstruction

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Keywords

  • VivAer
  • Nasal airway obstruction
  • Aerin Medical
03

In context

Nasal Obstruction

173 studies on the registry are indexed under Nasal Obstruction; 31 are open to participants now.

This study's planned enrollment of 30 is below the median of 70 across 139 interventional studies indexed under Nasal Obstruction.

Browse Nasal Obstruction studies →

Lead sponsor

Aerin Medical is the lead sponsor of 15 studies on the registry; 1 is open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 22 to 85 years old (inclusively).
  2. Willing and able to provide consent.
  3. Willing and able to comply with the patient-specific requirements and follow-up schedule outlined in the study protocol.
  4. Has a NOSE Score of ≥ 55.
  5. Has a documented diagnosis of NAO with NVC (static or dynamic) as the primary driver of NAO symptoms.
  6. Has a documented positive Modified Cottle Maneuver (using curette or equivalent to perform maneuver and evaluate nasal valve function).

Exclusion criteria

Exclusion Criteria:

  1. Has had rhinoplasty, septoplasty, inferior turbinate reduction or functional endoscopic surgery (FESS) within the preceding 3 months.
  2. Has uncontrolled chronic rhinitis as a contributor to nasal obstruction symptoms.
  3. Has a complex nasal anatomy (e.g., anatomical deformity) or a history of significant nasal trauma that is a potential contributor to nasal obstruction symptoms.
  4. Has any intranasal conditions that preclude adequate visualization of the nasal valve area.
  5. Has a medical condition(s) that may impair normal healing processes.
  6. Any adjunctive surgical or other nasal procedure (e.g., concha bullosa resection, inferior turbinate out fracture, septoplasty, etc.) on the same day or planned within 6 months of the study procedure.
  7. Has current or recent (within 30 days prior to screening) exposure to oral systemic or is expected to require oral corticosteroid therapy during the course of the study.
  8. Has nasal polyps, or a history of nasal polyps requiring medical or surgical treatment within the past 12 months.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Other
    VivAer Treatment

    Device: VivAer Stylus

Interventions

  • DeviceVivAer Stylus

    Bipolar radiofrequency energy delivered to the lateral nasal wall at the upper lateral cartilage using the VivAer® Stylus and Aerin Console at device default settings (temperature 60°C, power 4 watts, treatment time 18 seconds, cooling time 12 seconds) to remodel submucosal tissue, including cartilage, in the internal nasal valve area.

06

What researchers measure

Primary outcomes

  1. Change in nasal valve angle and cross-sectional area

    Quantitatively assess anatomic improvement of the internal nasal valve (INV) and nasal airway following VivAer treatment using VISIONAIR™ analysis.

    Time frame: Baseline to 3- and 6-months post-procedure.

07

Study locations

1 of 1 sites recruiting
  • ENT & Allergy of Delaware
    Newark, Delaware 19713, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — This is a small post-market study with a limited sample size, proprietary devices (VivAer® and VISIONAIR™), and no stated plan in the protocol to share individual participant data with outside researchers. Sharing IPD is generally more relevant for larger clinical trials.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 30, 2026
Sites
1 site added — first site in United States
Show site
  • ENT & Allergy of Delaware · Newark, United States
Oct 30, 2026
Start date
Jul 2026→Nov 2026
Oct 30, 2026
Primary completion
Mar 2027→May 2027
Oct 30, 2026
Study completion
May 2027→Aug 2027
Oct 30, 2026
Contact
Study contact changed: n•••@aerinmedical.com · •••9452→t•••@aerinmedical.com · •••6596; removed t•••@aerinmedical.com. See the current contact
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    Not yet recruiting→Recruiting
    1 site added — first site in United States
    Show site
    • ENT & Allergy of Delaware · Newark, United States
    Start date Jul 2026→Nov 2026
    Primary completion Mar 2027→May 2027
    Study completion May 2027→Aug 2027
    Contact Study contact changed: n•••@aerinmedical.com · •••9452→t•••@aerinmedical.com · •••6596; removed t•••@aerinmedical.com. See the current contact
    + 2 other changes: verification date and oversight details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07574918
Lead sponsor
Aerin Medical
Responsible party
Sponsor
First posted
May 8, 2026
Start date
Nov 2026 (estimated)
Primary completion
May 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Oct 30, 2026

Study contacts

Tien Dang, MS
Contact
tdang@aerinmedical.com
6692566596

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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