CClinicalTrials.gg
Not yet recruitingNCT07574918BREATHE AIUpdated May 14, 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. Not yet recruiting. Open to participants aged 22 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-05-14.

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

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

Browse trials for

Keywords

  • VivAer
  • Nasal airway obstruction
  • Aerin Medical
03

Who can participate

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

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 corticosteroids 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.
04

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.

05

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.

06

Study locations

No study locations are listed for this record.

07

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.

08

Registry details

Key details

Study ID
NCT07574918
Lead sponsor
Aerin Medical
Responsible party
Sponsor
First posted
May 8, 2026
Start date
Jul 2026 (estimated)
Primary completion
Mar 2027 (estimated)
Completion
May 2027 (estimated)
Last update
May 14, 2026

Study contacts

Neda Haque
Contact
nhaque@aerinmedical.com
(408) 784-9452
Tien Dang
Contact
tdang@aerinmedical.com

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion