NCT04769596已完成不适用
Safety and Efficacy Study of the Neurent Medical NEUROMARK System in Subjects With Chronic Rhinitis A Double-blind, Sham Controlled Study
Neurent Medical16 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2021年2月23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
- 143
- 试验地点
- 16
- 主要终点
- Frequency of Serious Adverse Events (SAEs) directly attributable to the device
研究概览
简要总结
A randomized, sham-controlled, double-blind study of the NEUROMARKTM system as a treatment for chronic rhinitis
详细描述
The MERIDIEN Study is a prospective, multi-center, double-blind, randomized (1:1), sham-controlled, cross-over study to evaluate the safety and efficacy of the NEUROMARK™ System in patients with Chronic Rhinitis.
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
Subjects, site investigator, site personnel, and sponsor will be blinded to which study arm they are randomized to.
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 provides written informed consent, including authorization to release health information.
- •Subject is 18 years of age or older at the time of consent.
- •Subject has provided a negative pregnancy test (if Subject is a woman of childbearing potential (WOCBP).
- •Subject WOCBP must be practicing and willing to continue an effective method of birth control during the course of the study.
- •Subjects stated willingness to comply with all study procedures, post- treatment care and availability for the duration of the study follow up of 1 year.
- •Subject tests negative for active COVID-19 at the start of study screening and continues to be free from COVID-19 symptoms until the time of enrollment/treatment.
- •Subject understands and agrees to follow local COVID-19 restrictions (social distancing, face mask, etc.)
排除标准
- •Subject has an allergy or intolerance to anaesthetic agent or other study-required materials.
- •Subject is an active smoker or has been a smoker within the last 6 months (patient reported).
- •Any physical condition that in the Investigator's opinion would prevent adequate study participation or pose increased risk to the study Subject.
- •Subject is pregnant, nursing or plans to become pregnant during the study, or is a WOCBP, but is not willing to use an effective method of birth control.
- •Patient is enrolled in an investigational drug or device study or has participated in such a study within the last 30 days prior to screening that in the opinion of the Investigator would interfere with the study results
- •Patient presents with any condition or situation which, in the Investigator's opinion, puts the Subject at risk, could confound the study results, or may interfere significantly with the Subject's participation in the study.
结局指标
主要结局
Frequency of Serious Adverse Events (SAEs) directly attributable to the device
时间窗: 1 month
Safety
次要结局
未报告次要终点
研究者
研究点 (16)
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