Recruiting

VivAer

Sponsor:

Aerin Medical

Code:

NCT07574918

Conditions

Nasal Airway Obstruction

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Interventions

VivAer Stylus

Study Details

Brief 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.

Conditions

Nasal Airway Obstruction

Study ID

NCT07574918

Start date

Nov, 2026

Status verified date

Oct, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

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:

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: VivAer Treatment

Interventions

VivAer 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.

Primary outcome measure

  • Change in nasal valve angle and cross-sectional area [ Time Frame: Baseline to 3- and 6-months post-procedure. ]

Central Contacts and Locations

Central contacts

Locations

ENT & Allergy of Delaware

Recruiting

Newark, Delaware, United States, 19713

Contacts

More Information

Sponsor

Aerin Medical

Last update posted

Oct 30, 2026

Last verified

Oct, 2026

Keywords

  • VivAer
  • Nasal airway obstruction
  • Aerin Medical

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-31. This information was provided to ClinicalTrials.gov by Aerin Medical on 2026-10-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.