Measuring Nasal Airway Changes After VivAer Treatment Using AI Analysis
ConditionNasal Airway Obstruction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-85
SponsorAerin Medical
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- VivAer Stylus
Treatment groups
30 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov