NCT07574918

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 SF-12 Health Survey.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
10mo left

Started Jul 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

May 4, 2026

Last Update Submit

May 4, 2026

Conditions

Nasal Airway Obstruction

Keywords

VivAerNasal airway obstructionAerin Medical

Outcome Measures

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.

    Baseline to 3- and 6-months post-procedure.

Study Arms (1)

VivAer Treatment

OTHER
Device: VivAer Stylus

Interventions

VivAer StylusDEVICE

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.

VivAer Treatment

Eligibility Criteria

Age22 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Has had rhinoplasty, septoplasty, inferior turbinate reduction or functional endoscopic surgery (FESS) within the preceding 3 months.
  • Has uncontrolled chronic rhinitis as a contributor to nasal obstruction symptoms.
  • 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.
  • Has any intranasal conditions that preclude adequate visualization of the nasal valve area.
  • Has a medical condition(s) that may impair normal healing processes.
  • 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.
  • 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.
  • Has nasal polyps, or a history of nasal polyps requiring medical or surgical treatment within the past 12 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesAirway ObstructionRespiratory InsufficiencyRespiration DisordersOtorhinolaryngologic Diseases

Central Study Contacts

Neda Haque

CONTACT

(408) 784-9452nhaque@aerinmedical.com

Tien Dang

CONTACT

tdang@aerinmedical.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 8, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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.