Healthcare Utilization and Outcomes of FinESS Treatment in the Office
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 26
- 主要终点
- Sino-Nasal Outcomes Test
研究概览
简要总结
A prospective, nonrandomized trial to evaluate postoperative healthcare resource utilization after maxillary balloon antrostomy using FinESS Sinus Treatment in the physician's office.
详细描述
A prospective, nonrandomized trial to evaluate postoperative healthcare resource utilization after maxillary balloon antrostomy using FinESS Sinus Treatment in the physician's office. Also to demonstrate the long-term durability of FinESS Sinus Treatment performed in an office setting.
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
- •18 years or older
- •Male or female subjects
- •Diagnosis of rhinosinusitis (CT radiographic evidence and medical evaluation)
- •Willing to comply with protocol requirements
- •Able to provide consent
排除标准
- •Hemophilia
- •Cystic fibrosis
- •Ciliary dysfunction
- •Severe septal deviation causing obstruction of the ostiomeatal unit
- •Pregnant females
结局指标
主要结局
Sino-Nasal Outcomes Test
时间窗: Baseline and 12 months post procedure
The 20-item Sino-Nasal Outcomes Test (SNOT-20) is a validated, disease-specific patient-reported instrument designed to indicate the severity of rhinosinusitis symptoms. The SNOT-20 evaluates 20 symptoms on a scale from 0 ("no problem") to 5 ("problem as bad as it can be"). The overall SNOT-20 score is the average of the 20 symptoms scores providing a range from 0 to 5 with higher scores indicating worse symptoms. The minimal clinically important difference (MCID) has been determined to be a reduction of 0.8 or more in the overall SNOT-20 score.
次要结局
- Rhinosinusitis Symptom Inventory (RSI) Nasal Symptoms Domain(Baseline and 12 months post procedure)
- Rhinosinusitis Symptom Inventory (RSI) Facial Symptoms Domain(Baseline and 12 months post procedure)
- Rhinosinusitis Symptom Inventory (RSI) Oropharyngeal Symptoms Domain(Baseline and 12 months post procedure)
- Number of Participants With Device and/or Procedure-related Adverse Events(Baseline through 12 months post procedure)
- Rhinosinusitis Symptom Inventory (RSI) Systemic Symptoms Domain(Baseline and 12 months post procedure)
- Number of Participants Using Nasal Steroids(Baseline and 12 months post procedure)
- Number of Participants Using Antihistamines(Baseline and 12 months post procedure)
- Number of Participants Using Antibiotics(Baseline and 12 months post procedure)