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Recruiting Not applicable Interventional

Measuring Nasal Airway Changes After VivAer Treatment Using AI Analysis

ClinicalTrials.gov ID: NCT07574918

Public ClinicalTrials.gov record NCT07574918. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 8, 2026, 6:50 AM EST

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Official title

Quantitative Evaluation of Nasal Airway Remodeling Following Temperature-Controlled Radiofrequency Treatment for Nasal Airway Obstruction Using AI-Assisted Analysis (BREATHE AI)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT07574918
Recruitment status
Recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Aerin Medical
Industry
Enrollment
30 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
22 Years to 85 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 2026 (Estimated)
Primary completion
May 2027 (Estimated)
Completion
Aug 2027 (Estimated)
Last update posted
Oct 30, 2026

2026 – 2027

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
ENT & Allergy of Delaware Newark Delaware 19713 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07574918, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 30, 2026 · Synced Nov 8, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07574918 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →