The Vivaer® Procedure for Treatment of Nasal Airway Obstruction - A ProspecTive, Multicenter Randomized Controlled TriAl Comparing Vivaer to Sham Control (VATRAC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 22
- 主要终点
- Nasal Obstruction Symptom Evaluation (NOSE) Scale - 3 Month Responder Rate
研究概览
简要总结
The purpose of this study is to compare the Vivaer procedure with radiofrequency (RF) energy to sham procedure for treatment of nasal airway obstruction (NAO).
详细描述
The purpose of this study is to compare the Vivaer procedure for treatment of nasal airway obstruction (NAO) with a sham procedure that simulates the actual procedure as closely as possible absent the delivery of radiofrequency (RF) energy to the nasal tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participant will be blinded to the study arm they are assigned to.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 85 years (inclusively).
- •Willing and able to provide informed consent.
- •Willing and able to comply with the subject-specific requirements outlined in the Study Protocol.
- •Seeking treatment for nasal obstruction and willing to undergo an office-based procedure.
- •Baseline Nasal Obstruction Symptom Evaluation (NOSE) Scale score ≥
- •Nasal valve is a primary or significant contributor to the patient's nasal obstruction as determined by the study investigator (based on clinical presentation, physical examination, nasal endoscopy, etc.) and the patient has a positive response to any of the following temporary measures (based on patient history or office exam):
- •Use of external nasal dilator strips (eg, Breathe Right Strips)
- •Use of internal nasal dilator cones
- •Modified Cottle Maneuver (manual elevation of the lateral nasal wall using a small instrument or cotton-tipped applicator to open the nasal valve)
- •Cottle Maneuver (manual lateral retraction of the cheek to open the nasal valve)
- •Dissatisfaction with medical management as judged by the patient. Defined as failed medical therapy (eg, decongestants, antihistamines, and/or nasal sprays for an appropriate period of time), but a positive response to internal or external nasal dilators.
排除标准
- •Prior surgery of the lateral nasal wall, including cephalic resection of the lower lateral cartilage, dome division or suture plication, alar graft or spreader graft placement.
- •Rhinoplasty, septoplasty, inferior turbinate reduction or functional endoscopic sinus surgery (FESS) within the preceding 3 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 patient's nasal obstruction symptoms and warranting surgical intervention.
- •Any adjunctive surgical nasal procedure planned on the same day or within 6 months after the Vivaer procedure.
- •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 patient to poor wound healing or increased surgical risk, or poor compliance with the requirements of the study.
结局指标
主要结局
Nasal Obstruction Symptom Evaluation (NOSE) Scale - 3 Month Responder Rate
时间窗: 3 months visit following the study procedure.
The Nasal Obstruction Symptom Evaluation (NOSE) Scale is a patient self-reported questionnaire consisting of 5 symptoms of nasal obstruction: nasal congestion, nasal blockage, trouble breathing, trouble sleeping, and getting enough air during exercise. Patients will report over the past 1 month how much the symptoms have been a problem. Total score ranges from 0 to 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.
次要结局
- Nasal Obstruction Symptom Evaluation (NOSE) Scale Mean Change From Baseline Through 3 Months(Change from Baseline to 3 months following the study procedure.)
- Percentage of Participants With Treatment Related Events (Safety) - Through 3 Months(At or following the study procedure up to to 3 months.)