Clinical Evaluation of Confirm the Safety and Efficacy of Balloon Sinuplasty Devices in the Treatment of Pediatric Sinusitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months
研究概览
简要总结
A non-randomized, multi-center, prospective, clinical study intended to evaluate the safety and efficacy of balloon sinuplasty devices in pediatric patients with longstanding sinusitis following failed medical management.
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
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 2 and < 18 years
- •Both male and female patients eligible
- •Planned surgical intervention (i.e. endoscopic sinus surgery, adenoidectomy, sinus irrigation for obtaining a culture) recommended by PI, consented to by patient's legal guardian)
- •Longstanding sinusitis: >3 mo symptoms OR 6 episodes/yr AND failed 2 courses antibiotics followed by positive CT scan
排除标准
- •Extensive previous sinonasal surgery in target ostia
- •Cystic fibrosis
- •Extensive sinonasal osteoneogenesis
- •Sinonasal tumors or obstructive lesions
- •History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium
- •Ciliary dysfunction
- •For female patients of childbearing age: the patient is either pregnant or lactating
结局指标
主要结局
Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months
时间窗: 12 months
Number of device-related adverse events from time of procedure through 12 months post-procedure.
Effectiveness: Change in Sinus Symptom Scores (SN-5)
时间窗: 12 months
Change in sinus symptoms (mean reduction) for subjects less than 12 years of age evaluated using the SN-5 questionnaire at 52 weeks post-procedure compared to baseline. The maximum possible score for the SN-5 is seven and the minimum is one. A reduction in SN-5 score indicates improvement.
Effectiveness: Change in Sinus Symptom Scores (SNOT-20)
时间窗: 12 months
Change in sinus symptoms (mean reduction) for subjects 12 years of age or greater evaluated using the SNOT-20 questionnaire at 52 weeks post-procedure compared to baseline. The maximum possible score for the SNOT-20 is five and the minimum is zero. A reduction is SNOT-20 score indicates improvement.
次要结局
- Revision Rate(at 1 year)
- Effectiveness: Medication Thru 1 yr(12 months)
- Effectiveness of Dilation/Measured by Post-op Interventions(12 months)
- Days Out of School During the 12 Months of Follow-up(12 months)
- Device Success: Ability to Access/Dilate Sinus Ostia(12 months)