NCT01054703终止不适用
Clinical Evaluation of the Safety and Feasibility of the Ethmoid Sinus Spacer and Access System With Drug (SPACER)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Occurrence of Adverse Events at the Time of the Procedure and Cumulatively up to 6 Weeks Post-implant
研究概览
简要总结
Evaluation of treatment of the ethmoid sinuses with the Ethmoid Sinus Spacer and Access system
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 21 years old
- •Both male and female
- •Ethmoid disease on CT scan
- •At least one non-ethmoid sinus requiring treatment
- •Failed medical management and symptomatic
排除标准
- •Previous ethmoid surgery
- •Not sufficient room for placement of Spacer
- •Patient requires septoplasty
- •Has received steroid treatment with in 2 weeks
- •Extensive sinonasal osteoneogenesis preventing device placement
- •Sinonasal tumors or obstructive lesions
- •History of facial trauma that distorts sinus anatomy
- •Asthmatic patients with aspirin sensitivity
- •Pregnant or lactating females
结局指标
主要结局
Occurrence of Adverse Events at the Time of the Procedure and Cumulatively up to 6 Weeks Post-implant
时间窗: Procedural and 6 weeks post-implant
次要结局
- Efficacy: Improvement in Ethmoid Sinus Health as Demonstrated by CT Scan and Quality-of-life Measures(1 wk, 2wk, 4wk, 6wk)
研究者
研究点 (2)
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