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Klinische Studie

Measuring Nasal Airway Changes After VivAer Treatment Using AI Analysis

NCT: NCT07574918 · NOT_YET_RECRUITING

NCT-IDNCT07574918
Medizinische Daten: StatusNOT_YET_RECRUITING
SponsorAerin Medical (INDUSTRY)
First posted
Last updated

Kurzzusammenfassung

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.

Offizielle Quelle

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