SinuSys Patency of Frontal Recess and Sphenoid Sinus Ostia Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Patency of treated target site
研究概览
简要总结
The goal of this study is to evaluate basic usability and confirm expected safety and effectiveness of SinuSys Dilation System when used to dilate frontal recess and sphenoid sinus ostia in patients with chronic rhinosinusitis.
详细描述
A multicenter, single arm, prospective study conducted to assess the safety and effectiveness of an osmotically-drive, low-pressure expansion device for dilation of frontal recess and sphenoid sinus ostia in patients with chronic rhinosinusitis (CRS).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of CRS
- •Subject in in need of frontal recess and/or sphenoid sinus dilation
排除标准
- •Pregnant or breastfeeding females
- •Previous treatment site intervention
- •Cystic fibrosis, aspirin sensitivity, steroid dependent asthma, sinonasal tumors, allergic fungal sinusitis, ciliary dysfunction, atrophic nasal mucosa, excessive osteogenesis that might preclude dilation
研究组 & 干预措施
SinuSys Dilation System
Opening of previously constrained frontal recess and/or sphenoid sinus ostia via dilation procedure (sinuplasty)
干预措施: Sinusys Dilation System (Device)
结局指标
主要结局
Patency of treated target site
时间窗: Patency immediately post device expansion and removal
Patency assessed by investigator via endoscopic evaluation of the target site
次要结局
- Patency of treated target site(1 month and 3 months)
- Reports of sinus related adverse events during the 3 months follow-up period(up to 3 months)