NCT01623050已完成1 期
SinuSys Patency of Maxillary Sinus Ostia Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 9
- 主要终点
- Patency of Treated Area
研究概览
简要总结
The purpose of this study is to assess safety and performance of the SinuSys Dilation System for dilation of the maxillary sinus ostium.
详细描述
A multicenter, single-arm, prospective study conducted to assess the safety and effectiveness of a new osmotically-driven, low-pressure expansion device for dilation of maxillary sinus ostia in patients with (CRS) Chronic Rhinosinusitis
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 chronic maxillary sinusitis
排除标准
- •Previous antrostomy
- •Sinonasal tumours
- •Cystic fibrosis
- •History of facial trauma that distorts sinus anatomy and precludes access to the maxillary sinus
- •Pregnant or breastfeeding females
- •Currently participating in another drug or device study
结局指标
主要结局
Patency of Treated Area
时间窗: Immediately post procedure
次要结局
- Patency of Treated Area(12 months)
- Number of Participants With Device-related Adverse Events as a Measure of Safety(3 months)
研究者
研究点 (9)
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