Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 115
- 主要终点
- Number of Sinuses With Patency of Sinus Ostium After Sinuplasty
研究概览
简要总结
A multi-center, non-randomized, prospective post-market evaluation of sinuplasty in paranasal sinuses.
详细描述
Sinusitis is a common healthcare problem that significantly reduces quality of life for people around the world. Patients suffer from headache, facial discomfort, nasal congestion, nasal drainage, loss of the sense of smell and malaise. Sinusitis is responsible for major healthcare expenditure and loss of workplace productivity.
The rationale of this study is to collect data on the effectiveness and safety of balloon dilation of the Frontal, Maxillary and Sphenoid sinuses by treating patients and observing them for a six month period of time following the procedure. Six month follow-up data is important to demonstrate the effectiveness of balloon catheter dilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Age 18 years and greater
- •Both male and female patients eligible
- •Diagnosis of chronic sinusitis that is not responsive to medical management
- •Planned endoscopic sinus surgery (recommended by PI, consented to by patient)
排除标准
- •Extensive sinonasal polyps
- •Extensive previous sinonasal surgery
- •Extensive sinonasal osteoneogenesis
- •Cystic fibrosis
- •Sampter's Triad (Aspirin sensitivity, Asthma, Sinonasal polyposis)
- •Sinonasal tumors or obstructive lesions
- •History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium
- •Ciliary dysfunction
- •Pregnant females
结局指标
主要结局
Number of Sinuses With Patency of Sinus Ostium After Sinuplasty
时间窗: 24 weeks
Patency of sinus ostium after sinuplasty will be determined by nasal endoscopic examination. The investigator will make a clinical judgment as to whether or not this has been achieved.
Number of Participants With Adverse Events Following Sinuplasty Procedure
时间窗: 24 weeks
Adverse event rate at 24 weeks: comprised of all observed peri-operative adverse events which were recorded on dedicated CRFs and any observed or patient-reported post-operative adverse events will be similarly recorded (through 24 week follow-up).
次要结局
- Number of Participants Experiencing Relief of Sinus Symptoms(Week 24)