NCT04277507已完成不适用
A Prospective, Multicenter Study of the AERin Medical Vivaer® ARC Stylus for Nasal AirWAY Obstruction (AERWAY)
Aerin Medical19 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2020年2月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 19
- 主要终点
- Change in Nasal Obstructive Symptom Evaluation (NOSE) Scores From Baseline to 3 Months
研究概览
简要总结
Post-market study to continue to evaluate the effectiveness of the Vivaer® ARC Stylus for nasal airway obstruction
详细描述
Prospective, Multicenter, Non-randomized Study of the Aerin Medical Vivaer® ARC Stylus for Nasal Airway Obstruction to continue to evaluate the effectiveness of the Vivaer® ARC Stylus for treating 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Willing and able to provide informed consent
- •Willing and able to comply with the study protocol
- •Seeking treatment for nasal obstruction
- •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 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
- •Anatomy that requires an adjunctive surgical nasal procedure on the same day or 3 months after the Vivaer procedure
- •Medical conditions which in the opinion of the treating physician would predispose the subject to poor wound healing or increased surgical risk.
结局指标
主要结局
Change in Nasal Obstructive Symptom Evaluation (NOSE) Scores From Baseline to 3 Months
时间窗: 3 Month
Mean change in NOSE score from Baseline to 3 months.Scores may range from the best score of 0, meaning no nasal obstructive symptoms to the worst score of 100, meaning severe nasal obstructive symptoms.
次要结局
未报告次要终点
研究者
研究点 (19)
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