A Prospective, Non-Randomized Study to Evaluate Treatment Outcome of Nasal Airway Obstruction Using the Aerin Medical Vivaer™ Stylus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in NOSE Score
研究概览
简要总结
This study evaluates subjective and objective measures of treatment outcome after using the Aerin Medical Vivaer™ Stylus to treat nasal obstruction
详细描述
This is a non-significant risk, prospective, non-randomized study to evaluate subjective and objective measures of nasal obstruction both before and after treatment with the Vivaer Stylus. The Stylus is used to deliver radiofrequency (RF) energy to the nasal valve area to improve symptoms in those diagnosed with nasal airway obstruction.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Complaints of nasal obstruction for at least 1 year
- •Failed maximum medical therapy (4-6 weeks of steroids)
- •Nasal Obstruction Symptom Evaluation (NOSE) score of ≥ 60 at Baseline
- •Nasal valve is a primary or significant contributor to the subject's nasal obstruction as determined by the study investigator (based on clinical presentation, physical examination, nasal endoscopy, etc.) and the subject has a positive response to any of the following temporary measures (based on patient history or during office exam):
- •Use of external nasal dilator strips (e.g., Breathe Right Strips)
- •Q-Tip test (manual intranasal lateralization)
- •Use of nasal stents
- •Cottle Maneuver (manual lateral retraction of the cheek)
排除标准
- •Prior surgical treatment of the nasal valve
- •Rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past three (3) months
- •Severe and/or chronic sinusitis, recurrent sinusitis, or allergies leading to nasal obstruction and currently requiring oral corticosteroid therapy
- •Severe case of any of the following: septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be the primary contributor to the subject's nasal obstruction symptoms and warranting surgical intervention
- •Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure session
- •Known or suspected to be pregnant, or is lactating
- •Other medical conditions which in the opinion of the investigator could predispose the subject to poor wound healing or increased surgical risk
结局指标
主要结局
Change in NOSE Score
时间窗: Baseline, 90 days
Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline to 90 days post-study procedure. Improvement (90 day score - baseline score) is signified by a negative value. The Nasal Obstruction Symptom Evaluation (NOSE) scale is a validated disease-specific health status outcomes instrument, used to assess severity of nasal obstruction symptoms. Score ranges from 0 to 100. Higher scores indicate increased symptoms/symptom severity.
Change in VAS of Nasal Obstruction
时间窗: Baseline, 90 days
Change in visual-analog scale (VAS) of nasal obstruction severity as perceived by the subject from baseline to 90 days post-study procedure. Improvement (90-day score - baseline score) is signified by a negative value. The visual-analog scale (VAS) of nasal obstruction is presented to the subject as a 10cm line anchored on each end by verbal descriptors: 0 = No Obstruction and 10 = Completely Obstructed. The subject is asked to place a vertical mark on the line to show the level of nasal obstruction they feel. The distance between 0 and the vertical mark made by the subject is measured and the results is expressed in centimeters. Higher scores indicate more severe obstruction.
次要结局
未报告次要终点