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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
VivAer Stylus
DeviceBipolar 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: VivAer TreatmentOther 1 intervention
Trial outcomes
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.
Time frame
Baseline to 3- and 6-months post-procedure.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: