NCT06773013已完成不适用
Safety and Effectiveness of Sonu Acoustic Resonance Therapy for the Treatment of Pediatric Patients With Moderate to Severe Nasal Congestion.
Third Wave Therapeutics2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2025年1月9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
- 31
- 试验地点
- 2
- 主要终点
- Serious adverse events
研究概览
简要总结
To demonstrate the safety and effectiveness of Sonu for the treatment of pediatric patients with moderate to severe nasal congestion.
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
- 12 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric subjects between the ages of 12 to 21 years
- •Present with symptoms of nasal congestion for 1 month or more prior to treatment
- •Have a 24 hour reflective nasal congestion subscore of the TNSS of 2 or more on a 0 to 3 scale at the time of screening
排除标准
- •Head, nasal or sinus surgery within 3 months
- •Sinus infection diagnosed within the last month, or rhinitis medicamentosa
- •Documented history of nasal polyposis or mass
- •Pregnancy
结局指标
主要结局
Serious adverse events
时间窗: 2 weeks
Safety
Reduction in nasal congestion subscore
时间窗: 2 weeks
Effectiveness
次要结局
- Adverse events(2 weeks)
- Total Nasal Symptom Score (TNSS)(2 weeks)
研究者
研究点 (2)
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