Measuring Nasal Airway Changes After VivAer Treatment Using AI Analysis

Официальное название

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

Обзор

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.

Вмешательства

• Устройство VivAer Stylus
  Bipolar 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.

Первичные конечные точки

• Change in nasal valve angle and cross-sectional area [Срок оценки: Baseline to 3- and 6-months post-procedure.]

Критерии участия

Критерии включения

• 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.
• Has a documented diagnosis of NAO with NVC (static or dynamic) as the primary driver of NAO symptoms.
• Has a documented positive Modified Cottle Maneuver (using curette or equivalent to perform maneuver and evaluate nasal valve function).

Критерии исключения

• 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.
• Has a medical condition(s) that may impair normal healing processes.
• Any adjunctive surgical or other nasal procedure (e.g., concha bullosa resection, inferior turbinate out fracture, septoplasty, etc.) on the same day or planned within 6 months of the study procedure.
• Has current or recent (within 30 days prior to screening) exposure to oral systemic corticosteroids or is expected to require oral corticosteroid therapy during the course of the study.
• Has nasal polyps, or a history of nasal polyps requiring medical or surgical treatment within the past 12 months.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07574918 · CTP2527

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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