A Prospective, Multi-Center Non-Randomized Study to Evaluate Treatment of Nasal Airway Obstruction Using the Aerin Medical Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 14
- 主要终点
- Improvement in NOSE Score
研究概览
简要总结
Evaluation of the Aerin Medical Device used for the treatment of nasal obstruction.
详细描述
This is a non-significant risk, prospective, multi-center, non-randomized study to evaluate the safety and efficacy of the Aerin Medical device (Vivaer Stylus) when 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
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Seeking treatment for nasal obstruction and willing to undergo an office-based procedure
- •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 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 twelve (12) months
- •Chronic sinusitis, recurrent sinusitis, or allergies leading to nasal obstruction
- •Septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be a significant contributor to the subject's nasal obstruction symptoms
- •Known or suspected allergies or contraindications for any general or local anesthetic agents and / or any antibiotic medications
- •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
研究组 & 干预措施
Vivaer Stylus
Intervention: Procedure: thermal treatment of submucosal tissue including cartilage in the internal nasal valve area
干预措施: Vivaer Stylus (Device)
结局指标
主要结局
Improvement in NOSE Score
时间窗: Baseline, 26 weeks
Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline to 26 weeks post-study procedure. Improvement (baseline score - 26-week score) is signified by a positive 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.
次要结局
- NOSE Responder Rate(Baseline, 26 weeks)
- Percentage of Participants With Treatment-Related Adverse Events (Safety)(Baseline through 26 weeks)