Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07574918 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Measuring Nasal Airway Changes After VivAer Treatment Using AI Analysis

Study acronym: BREATHE AI
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study title revisedv2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07574918
Lead Sponsor Aerin Medical
Conditions
(from sponsor)		 Nasal Airway Obstruction
Related terms Nasal Obstruction
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov