Quantitative Evaluation of Nasal Airway Remodeling Following Temperature-Controlled Radiofrequency Treatment for Nasal Airway Obstruction Using AI-Assisted Analysis (BREATHE AI)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Change in nasal valve angle and cross-sectional area
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •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).
排除标准
- •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.
研究组 & 干预措施
VivAer Treatment
干预措施: VivAer Stylus (Device)
结局指标
主要结局
Change in nasal valve angle and cross-sectional area
时间窗: Baseline to 3- and 6-months post-procedure.
Quantitatively assess anatomic improvement of the internal nasal valve (INV) and nasal airway following VivAer treatment using VISIONAIR™ analysis.
次要结局
未报告次要终点