Interventional Registry to Collect Real-World Evidence of the NEUROMARK System in Subjects With Chronic Rhinitis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 16
- 主要终点
- Efficacy - reflective Total Nasal Symptom Score (rTNSS)
研究概览
简要总结
The NEUROMARK Registry Study is a prospective, multicenter, single-arm, post-market, interventional registry study to collect real-world evidence of the NEUROMARK System in subjects with chronic rhinitis.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject MUST:
- •Be ≥18 years of age.
- •Be scheduled to receive treatment with the commercially available NEUROMARK System consistent with the device's indications for use.
- •Have moderate to severe symptoms of running nose (individual rTNSS symptom rating of 2 or 3), mild to severe symptoms of nasal congestion (individual rTNSS symptom rating of 1, 2, or 3), and a minimum total score of 5 (out of 12) at screening.
- •Be willing and able to provide consent and comply with all study elements, as indicated by written informed consent.
排除标准
- •Subjects Must Not:
- •1. Have a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months.
研究组 & 干预措施
NEUROMARK Treatment
Interventional registry to collect real world data - Subjects will undergo treatment with the NEUROMARK System.
干预措施: NEUROMARK System (Device)
结局指标
主要结局
Efficacy - reflective Total Nasal Symptom Score (rTNSS)
时间窗: 36-month follow-up
Efficacy, as assessed by the mean change from baseline in the reflective Total Nasal Symptom Score (rTNSS) total score at each follow-up
Safety - incidence of device- and/or procedure-related serious adverse
时间窗: 36-month follow-up
Safety, as assessed by the incidence of device- and/or procedure-related serious adverse events (SAEs).
次要结局
未报告次要终点