Randomized Controlled Trial Comparing NEUROMARK System to Sham Control in Patients With Chronic Rhinitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 16
- 主要终点
- rTNSS
研究概览
简要总结
The NEUROMARK RCT Study is a prospective, multicenter, randomized, sham-controlled, single-blinded, superiority trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
This is a single-blind study; participants will be blinded to the randomization assignment.
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
- •Participant Must:
- •Be ≥18 years of age.
- •Have been experiencing rhinitis symptoms for a minimum of 6 months.
- •Have moderate to severe symptoms of runny 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 baseline.
- •Be an appropriate candidate for bilateral NEUROMARK device treatment performed under local anesthesia.
- •Be willing and able to comply with all study elements, as indicated by written informed consent.
排除标准
- •Participant Must Not:
- •Have clinically significant anatomic obstruction that in the investigator's opinion limit access to the posterior nose, including but not limited to severe septal deviation or perforation, nasal polyps, and/or sinonasal tumor.
- •Have had previous sinus or nasal surgery within 6 months of study enrollment.
- •Have previously undergone RF, cryotherapy, or other surgical interventions for rhinitis.
- •Have rhinitis symptoms that are due to seasonal allergies only.
研究组 & 干预措施
Active
Subjects in this arm will undergo treatment with the NEUROMARK device.
干预措施: NEUROMARK System (Device)
Sham
Subjects in this arm will undergo the procedure with a Sham device. Sham control participants will be offered the option to receive active treatment after the 90-day follow-up provided they still meet all eligibility criteria.
干预措施: Sham NEUROMARK System (Device)
结局指标
主要结局
rTNSS
时间窗: 90-days post procedure follow-up
Comparison of the percentage of responders (participants with a 30% or greater reduction in rTNSS relative to baseline) between study arms at 90-days
次要结局
未报告次要终点