NCT05591989已完成不适用
Clinical Evaluation of Safety and Efficacy for the NEUROMARK System in Subjects With Chronic Rhinitis (PARAGON) - A Prospective, Single-arm, Multicenter Clinical Study.
Neurent Medical10 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年9月26日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 10
- 主要终点
- Change from Baseline in Total Reflective Total Nasal Symptom Score (rTNSS) at 6 Months [Efficacy]
研究概览
简要总结
The PARAGON 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
- •Subjects 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.
- •Have an allergy test (by skin prick or intradermal testing, or by a validated in vitroImmunoglobin E [IgE test]) on file within 5 years of the baseline visit or is willing to have one performed during the study prior to 6-month visit.
- •Be an appropriate candidate for bilateral NEUROMARK® device treatment performed under local anesthesia.
- •Test negative for active COVID-19 at the start of the study screening and continue to be free of COVID-19 symptoms until the time of enrollment/treatment.
- •Be willing and able to comply with all study elements, as indicated by written informed consent.
排除标准
- •Subjects 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 an active nasal or sinus infection.
- •Have nasal mucosal erosion/ulceration.
- •Have rhinitis symptoms that are due to seasonal allergies only.
- •Have plans to (or otherwise anticipates the need to) undergo an ENT procedure concurrently or within 6 months after the study procedure.
- •Have started a new sinonasal medication regimen within 4 weeks prior to treatment that, according to the manufacturer's labelling, has not yet stabilized.
- •Be on prescribed anticoagulants (eg, warfarin, Plavix) or ≥ 325 mg aspirin that cannot be held for an appropriate time before the procedure.
- •Have a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months.
- •Have numbness of the soft palate, excessive dry eye, excessive dry nose, or other indication of neuro/nerve compromise in the sinonasal cavity.
- •Have an active rhinitis medicamentosa or a history of rhinitis medicamentosa within the past 6 months.
- •Have been diagnosed with atrophic rhinitis.
- •Have had previous head and/or neck irradiation.
- •Have an allergy or intolerance to local anesthetic agents.
- •Be pregnant.
- •Have a physical, neurological, medical, psychiatric condition or situation that, 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.
- •Be participating in another clinical research study.
研究组 & 干预措施
Treatment
Experimental
Subjects will undergo treatment with the NEUROMARK System
干预措施: NEUROMARK System (Device)
结局指标
主要结局
Change from Baseline in Total Reflective Total Nasal Symptom Score (rTNSS) at 6 Months [Efficacy]
时间窗: Baseline to 6 months
The reflective Total Nasal Symptom Score (rTNSS) is a patient-reported outcome assessing nasal congestion, rhinorrhea, sneezing, and nasal itching. Each symptom is scored from 0 (none) to 3 (severe), with a total score range of 0 to 12. A decrease in score indicates improvement in symptoms.
Safety Outcome
时间窗: 24 months
Safety, as assessed by the incidence of device- and/or procedure related serious adverse events (SAEs)
Efficacy Outcome
时间窗: 6 months
Efficacy, as assessed by the mean change from baseline in nasal symptoms using the 4-symptom rTNSS (reflective Total Nasal Symptom Score) at 6-month follow-up (FU)
次要结局
- The mean change from baseline in Clinical Global Impression -Improvement (CGI-I) score(24 months)
- The mean change from baseline in rTNSS subscores(24 months)
- The mean change from baseline in rTNSS total score (except 6-month FU)(24 months)
- Percent of subject satisfaction at follow-up(24 months)
- Tolerability of treatment via verbal report using the Numeric Rating Scale (NRS) score(24 months)
- The mean change from baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ) score(24 months)
- Percentage of participants achieving ≥30% reduction from baseline in total rTNSS(6 months)
- Percentage of participants achieving minimal clinically important difference (MCID) in total rTNSS(6 months)
- Change from baseline in total Nasal Obstruction Symptom Evaluation (NOSE) score(Baseline to 6 months)
- Percentage of participants achieving response in total NOSE score(6 months)
- Change from baseline in overall mini-Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ) score(Baseline to 6 months)
- Percentage of participants achieving minimal clinically important difference (MCID) in overall mini-RQLQ(6 months)
- Change from baseline in overall Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7) score(Baseline to 6 months)
- Change from baseline in postnasal drip symptom score(Baseline to 6 months)
- Change from baseline in cough symptom score(Baseline to 6 months)
- Incidence of Device- and/or Procedure-Related Serious Adverse Events (SAEs)(6 months)
研究者
研究点 (10)
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