The Vivaer Procedure for Treatment of the Septal Swell Bodies for Airway Obstruction - A Prospective Open-Label Multicenter Study (SWELL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 18
- 主要终点
- Nasal Obstruction Symptom Evaluation (NOSE) Scale Mean Change
研究概览
简要总结
Post-market study to access the clinical use of the Vivaer Arc Stylus to treat Septal Swell Bodies (SSB).
详细描述
Prospective, Open-Label, Multicenter, Single Arm Study of the Aerin Medical Vivaer ARC Stylus to treat Septal Swell Bodies (SSB) to improve symptoms in adults diagnosed with nasal obstruction attributed to SSB.
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
- 是
入选标准
- •Age 22 to 85 years (inclusively).
- •Seeking treatment for nasal obstruction and willing to undergo an office-based procedure.
- •Baseline NOSE score ≥
- •Presence of SSB hypertrophy limiting visualization of the middle turbinate (MT) by more than 50%.
- •Reduction in size of the SSB after application of topical decongestant on a cotton plug directly to the SSB region.
- •Improvement in the symptoms of nasal obstruction after SSB decongestion suggesting that the SSB may play a role in nasal obstruction.
- •Willing and able to withhold anticoagulant medications during the perioperative period (3-day window on either side).
- •Willing and able to provide informed consent.
- •Willing and able to comply with the participant-specific requirements outlined in the study protocol.
排除标准
- •Rhinoplasty, septoplasty, inferior turbinate (IT) reduction, or other surgical nasal procedures within the preceding 6 months.
- •Severe case of any of the following: septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be the primary contributor to the participant's nasal obstruction symptoms and warranting surgical intervention.
- •Any adjunctive surgical nasal procedure planned on the same day or within 3 months after the Vivaer procedure.
- •Known or suspected allergies or contraindications for any general or local anesthetic agents.
- •Known or suspected to be pregnant or is lactating.
- •Participating in another clinical research study.
- •Other medical conditions which in the opinion of the investigator would predispose the participant to poor wound healing or increased surgical risk, or poor compliance with the requirements of the study.
- •Known or suspected regular use of oxymetazoline (Afrin) nasal decongestant or oral steroids.
- •For sites participating in the CT substudy only: Active sinus condition (eg, significant sinus diseases, infection or polyp formation) identified by CT.
结局指标
主要结局
Nasal Obstruction Symptom Evaluation (NOSE) Scale Mean Change
时间窗: 3 months (13 weeks) visit following screening
The primary endpoint is improvement in self-reported Nasal Obstruction Symptom Evaluation (NOSE) Scale score from baseline recorded at the screening evaluation to 13 weeks after the procedure. The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of participants treated for nasal obstruction.43 The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as mild (range, 5-25), moderate (range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE Scale survey.
次要结局
- Responder Percent(3 months (13 weeks) visit following baseline)
- Number of Participants With Device Related Adverse Events(At or following the study procedure up to 3 months.)