NCT00912405已完成不适用
A Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis
Intersect ENT1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Device Placement Success Rate
研究概览
简要总结
This study allows continued access to the Sinexus Intranasal Splint while a marketing application is being prepared. This study will generate additional performance, reimbursement and safety data for the steroid-eluting Sinexus Intranasal Splint when used following Functional Endoscopic Sinus Surgery (FESS) in patients with chronic sinusitis (CS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Patient is 18 years of age or older
- •Patient has a diagnosis of chronic sinusitis
- •Patient has a clinical indication for and has consented to FESS
- •Patient CT scan confirms CS diagnosis within 6 months of procedure
- •CT sacn confirms presence of disease in ethmoid sinus(es)
- •Planned FESS includes unilateral or bilateral total ethmoidectomy
排除标准
- •Immune deficiency (IGG subclass deficiency or IGA deficiency)
- •Oral-steroid dependent COPD, asthma or other condition
- •Clinical evidence of acute bacterial sinusitis
- •History or diagnosis of glaucoma or ocular hypertension
- •Clinical evidence or suspicion of invasive fungal sinusitis
- •Evidence of disease or condition expected to compromise survival or ability to complete follow-up
- •Known history of allergy or intolerance to corticosteroids
- •History of insulin dependent diabetes
结局指标
主要结局
Device Placement Success Rate
时间窗: At the time of procedure
A proportion where the numerator is the number of successful device placements and denominator is the number of attempted sinuses.
Safety as Determined by the Frequency of Serious Adverse Local Tissue Response (SALT)
时间窗: 30 days
次要结局
- Assessment of Changes From Baseline in Intra-ocular Pressure and Lens Opacities(Baseline and 30 days)
- Number of Sinuses With Significant Post-operative Adhesion Formation(30 days)
研究者
研究点 (1)
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