Low Temperature Controlled Radiofrequency Intranasal Remodeling Treatment of the Nasal Valve Area. A Multicentric Long-term Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 6
- 主要终点
- response rate Nose Score
研究概览
简要总结
A Prospective, Multicenter, Non-Randomized Study of the Aerin Medical Vivaer ARC Stylus for Nasal Airway Obstruction
详细描述
The primary objective of this post-market study is 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 using validated questionaires.
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
- •Eligible subject will meet all the following:
- •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
- •Eligible subjects will NOT meet any of the following:
- •Prior surgical treatment of the nasal valve
- •Rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past six months
- •Medical conditions which in the opinion of the treating physician would predispose the subject to poor wound healing or increased surgical risk.
- •Known or suspected to be pregnant or is lactating.
- •Any adjunctive surgical nasal procedure planned on the same day or within 24 months after the Vivaer procedure.
- •Current participation in any study or participation in any study less than 6 weeks before study date
结局指标
主要结局
response rate Nose Score
时间窗: 3 Months, 6, 12 and 24 months
The primary efficacy endpoint is the responder rate at 3 months after the procedure for the participants. Individual participant success (responder) is defined as at least 1 Nasal Obstruction Symptom Evaluation (NOSE) class improvement or an improvement (decrease) in NOSE score of 20% or more from baseline at the 3-month evaluation.
次要结局
- Efficacy measurement using the change in mean NOSE SCORE(3 Months, 6, 12 and 24 months)
- Safety Control regarding(3 Months, 6, 12 and 24 months)
研究者
Professor Dr. med. Detlef Brehmer
PI Prof. Dr. med. Detlef Brehmer
HNO-Praxis Alte Post