Safety and Efficacy Study of the Neurent Medical NEUROMARK™ System in Subjects With Chronic Rhinitis - A Prospective, Single-arm, Multicenter Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 8
- 主要终点
- Efficacy
研究概览
简要总结
The CLARITY Study is a prospective, single-arm, multicenter safety and efficacy study of the Neurent Medical 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 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.
- •Confirmation of moderate to severe symptoms of rhinorrhea. (VAS NSS score for runny nose ≥ 5.0 and rTNSS score for runny nose ≥ 2).
- •Confirmation of mild to severe symptoms of nasal congestion. (VAS NSS score ≥ 2.5 for stuffy nose (congestion) and rTNSS score of ≥ 1).
- •Confirmation that the total combined VAS NSS score is ≥ 10 for nasal congestion and runny nose.
- •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.).
- •Nasal anatomy appropriate to receive the NEUROMARK™ System.
- •Subject is experiencing long term chronic rhinitis. Subject has been experiencing symptoms of rhinitis for at least 6 months prior to enrollment, defined as: rhinorrhea, anterior runny nose AND congestion, blockage (stuffy nose, obstruction).
排除标准
- •Subject has clinically significant anatomic obstruction that limits access to the posterior nose as determined by the Study Investigator such as severe septal deviation, prior surgical considerations, cleft palate, nasal polyps, or sino-nasal tumor.
- •Subject has an active nasal or sinus infection at the time of treatment.
- •Subject has a diagnosis of Atrophic Rhinitis.
- •Subject has a Lund-Mackay score >3 during the screening phase, an active history of chronic sinusitis (within the last year).
- •Subject has a septal perforation or nasal mucosal erosion/ulceration.
- •Subject experiences numbness of the soft palate, excessive dry eye, excessive dry nose, or other indication of neuro/nerve compromise in the sino-nasal anatomy.
- •Subject has had prior sinus or nasal surgery that may prevent access or proper placement of the NEUROMARK™ System.
- •Subject has had prior head or neck irradiation (head/neck cancer therapy).
- •Subject has an allergy or intolerance to anaesthetic agent or other study-required materials.
- •Subject is taking anticoagulant medication or 325 mg aspirin that cannot be discontinued before the procedure and for the length of the study.
- •Subject has a history of nasal manifestation of rheumatic disease.
- •Subject has started a new sino-nasal medication regimen within 4 weeks prior to treatment (i.e. antihistamines, cromolyn, leukotriene receptor antagonists, inhaled or systemic steroids, anticholinergics, expectorants, decongestants) that, per the manufacturer's labelling, has not yet stabilized.
- •Subject has uncontrolled Hypothyroidism.
- •Subject has uncontrolled Hypertension (stage 2 or higher).
- •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.
- •Subject presents with acute sinusitis at time of treatment or other sino-nasal related illness other than rhinitis.
- •Subject has history of chronic epistaxis or nosebleed episodes within the last 12 months.
- •Subject has rhinitis symptoms due to seasonal allergies only.
- •Subject has received previous procedure or surgery for chronic rhinitis and/or to disrupt the posterior nasal nerve.
研究组 & 干预措施
Experimental: Treatment
Subjects will undergo treatment with the NEUROMARK System
干预措施: NEUROMARK System (Device)
结局指标
主要结局
Efficacy
时间窗: 3 months
Efficacy will be assessed by the change in Visual Analog Scale (VAS) Nasal Symptom Score (NSS) from baseline through 3 months for rhinorrhea and nasal congestion
Safety
时间窗: 1 month
Safety will be evaluated based on frequency of Serious Adverse Events (SAEs) directly attributable to the NEUROMARK System at one (1) month post index procedure.
Mean Change From Baseline in VAS Nasal Symptom Score (NSS) for Rhinorrhea at 3 Months
时间窗: 3 months
The Visual Analog Scale Nasal Symptom Score (VAS NSS) is a patient-reported outcome measure of nasal symptom severity. Each symptom item is scored on a scale of 0 to 10, where 0 indicates no symptoms and 10 indicates the worst possible symptoms; higher scores indicate worse outcomes. This measure reports the mean change from baseline to 3 months in VAS NSS for \[rhinorrhea\]. A negative change from baseline indicates improvement.
Mean Change From Baseline in VAS Nasal Symptom Score (NSS) for Nasal Congestion at 3 Months
时间窗: 3 months
The Visual Analog Scale Nasal Symptom Score (VAS NSS) is a patient-reported outcome measure of nasal symptom severity. Each symptom item is scored on a scale of 0 to 10, where 0 indicates no symptoms and 10 indicates the worst possible symptoms; higher scores indicate worse outcomes. This measure reports the mean change from baseline to 3 months in VAS NSS for \[nasal congestion\]. A negative change from baseline indicates improvement.
次要结局
未报告次要终点