A Prospective, Open-label, Multi-center, Non-inferiority Study Comparing VivAer® to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction (The CompAer Study).
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
- 试验地点
- 42
- 主要终点
- Nasal Obstruction Symptom Evaluation (NOSE) Scale
研究概览
简要总结
The purpose of this study is to compare the clinical outcomes of the VivAer procedure to functional rhinoplasty and septoplasty surgery for the treatment of nasal airway obstruction (NAO) to establish non-inferiority.
详细描述
The purpose of this study is to compare the clinical outcomes of the VivAer procedure to functional rhinoplasty and septoplasty surgery for the treatment of nasal airway obstruction (NAO) to establish non-inferiority by using the NOSE scale to evaluate the significance of a patient's nasal obstruction both before and after the procedure for the primary endpoint.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- 否
入选标准
- •Age 22 to 85 years old (inclusively).
- •Willing and able to provide consent.
- •Willing and able to comply with the patient-specific requirements outlined in the study protocol.
- •Has access to a mobile device, tablet, or computer with internet access and has access to an email address.
- •Seeking treatment for NAO
- •Has a NOSE Score of ≥55 indicating severe to extreme NAO.
- •Have a positive modified Cottle maneuver.
- •Planning either to undergo an intervention for NAO that includes one of the following as the primary approach:
- •VivAer procedure for repair of nasal valve dysfunction (may include inferior turbinate and septal swell body as additional treated areas)
- •Functional rhinoplasty surgery addressing the nasal valve and/or lateral nasal wall (may be combined with septoplasty with/without turbinoplasty performed alone or in combination).
- •Septoplasty surgery with turbinate reduction.
排除标准
- •Has had nasal surgery (including sinus surgery) within the last 3 months.
- •Has had a previous rhinoplasty (functional or cosmetic), septoplasty, inferior turbinate reduction, or VivAer procedure.
- •Has extreme nasal pathology, a history of extreme nasal injuries, or an abnormal nasal condition (e.g. septal perforation or empty nose syndrome) that may be exacerbated by surgery.
- •Has a medical condition(s) that may impair normal healing processes or be exacerbated by the stress of surgery.
- •Has chronic rhinitis that is refractory to medications or rhinitis medicamentosa.
- •Has poorly controlled chronic rhinosinusitis disease.
- •Rhinoplasty is being performed primarily for cosmesis.
- •Is receiving, planning to receive, or has received a Latera absorbable nasal implant at any time.
- •Planning to have sinus or cosmetic surgery (e.g., functional endoscopic sinus surgery, cosmetic rhinoplasty) or a surgery involving the airway (e.g., hypoglossal nerve stimulation surgery, uvuloplasty, tonsillectomy, tongue base or soft palate interventions) within 6 months following enrollment.
- •Is having an adjunctive surgical procedure performed with the primary NAO procedure (e.g. functional rhinoplasty with concha bullosa reduction, septoplasty with turbinate reduction performed with functional endoscopic sinus surgery)
研究组 & 干预措施
VivAer Arm
The VivAer treatment arm will be comprised of patients undergoing the minimally invasive VivAer procedure using the VivAer Stylus and Aerin Console. The VivAer Stylus is a disposable handheld device capable of delivering bipolar radiofrequency (RF) energy to tissue when connected to the Aerin Console radiofrequency generating device. Treatments will be performed using the VivAer Stylus and Aerin Console using non-overlapping and device default settings (temperature 60° C, power 4 watts, treatment time 18 seconds, and cooling time 12 seconds). VivAer treatment areas will include at minimum the lateral nasal wall in the area of the upper lateral cartilage and may also involve treatment of the inferior turbinate and/or septal swell body at the discretion of the investigator according to individual patient needs.
Surgical Comparator Arm
The two surgical intervention arms will be comprised of patients undergoing surgical intervention for the treatment of NAO as follows:
- Functional Rhinoplasty Arm: This arm will include patients undergoing primary functional rhinoplasty surgery for NAO addressing the nasal valve and/or lateral nasal wall and may be performed with septoplasty or turbinoplasty performed alone or in combination). This procedure may include minor aspects of cosmesis (e.g., dorsal hump reduction) at the discretion of the investigator.
- Septoplasty arm: This arm will include patients undergoing a septoplasty with or without turbinate reduction as the only procedures performed for NAO.
结局指标
主要结局
Nasal Obstruction Symptom Evaluation (NOSE) Scale
时间窗: 3 months, 6 months, 12 months and 24 months post-procedure.
To evaluate the significance of a patient's nasal obstruction both before and after the procedure for the primary endpoint, this study will use the well-known subjective patient-reported outcome measure, the NOSE Scale. The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure outcomes of participants treated for nasal obstruction. The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale with 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 survey. Individual participant success (treatment responder) is based on NOSE Scale improvement defined as a ≥ 24 point improvement (decrease) in NOSE Scale score from baseline to the 3-month evaluation.
次要结局
- Epworth Sleepiness Scale (ESS)(3 months, 6 months, 12 months and 24 months post-procedure.)
- 12-item Short Form (SF-12) Survey(3 months, 6 months, 12 months and 24 months post-procedure.)
- Visual Analogy Scale (VAS) Score(1 week post procedure)
- Return to Work(3 months post procedure.)
- Patient Satisfaction with Procedure(3 months, 6 months, 12 months and 24 months post-procedure.)
- Adverse Events(Through study completion, minimum 2 years)