Effect of Temperature-Controlled Radiofrequency Ablation of the Posterior Nasal Nerve on Inflammatory Biomarkers in Patients With Allergic and Nonallergic 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
- 25
- 试验地点
- 2
- 主要终点
- Change in expression of nasal mucosal inflammatory markers in allergic and nonallergic chronic rhinitis patients
研究概览
简要总结
Post-market study to continue to evaluate the effectiveness of the RhinAer Stylus for chronic rhinitis and the effect of treatment on inflammatory biomarkers.
详细描述
Prospective, Open Label, Multicenter Study of the Aerin Medical RhinAer® Stylus for Chronic Rhinitis to continue to evaluate the effectiveness of the RhinAer® Stylus for treating the posterior nasal nerve area to improve symptoms in adults diagnosed 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
- 22 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 22 to 85 years (inclusively).
- •Willing and able to provide informed consent.
- •Willing and able to comply with the patient-specific requirements outlined in the study protocol.
- •Presenting to the ENT office seeking evaluation and/or treatment for chronic rhinitis (allergic or nonallergic) of at least 12 months duration
- •Willing to undergo the RhinAer procedure
- •Has a baseline rTNSS symptom score of ≥6 at time of screening
- •If on anticoagulation therapy, anticoagulant medications can be withheld during the perioperative period (at least 3-day window pre- and post-procedure).
- •Has been diagnosed with either allergic or non-allergic chronic rhinitis and meet the following criteria:
- •a. Allergic rhinitis: diagnosed with perennial (non-seasonal) allergic rhinitis and has demonstrated sensitization to specific allergens through skin prick testing, specific IgE blood testing, or other allergy testing methods, confirming the allergic nature of their rhinitis within the past 24 months.
- •b. Nonallergic rhinitis: diagnosed with nonallergic rhinitis with demonstration of a negative skin prick testing, specific IgE blood testing, or other allergy testing methods, confirming the nonallergic nature of their rhinitis within the past 24 months.
排除标准
- •Anatomic obstructions in the nasal passage(s) that in the investigator's opinion limits access to the posterior nasal nerve treatment area.
- •Has seasonal rhinitis symptoms.
- •Current or recent use of biologic therapy within past 3 months.
- •History of chronic epistaxis or has had episodes of significant nose bleeds in the past 3 months.
- •Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure.
- •Known or suspected to be pregnant or is lactating.
- •Has any condition resulting in a predisposition to excessive bleeding (e.g., hereditary hemorrhagic telangiectasia [HHT]).
- •Has diagnosis of rhinitis medicamentosa, an active nasal or sinus infection or has a history of 'dry eye.'
- •Has had previous procedure or surgery for chronic rhinitis (e.g., PNN ablation).
- •Has had a nasal or sinus surgical procedure in the past six (6) months.
- •Currently participating in another clinical research study or has participated in an interventional study within the past 3 months.
- •Has a planned adjunctive procedure at the time of the study procedure or within the 6-month study follow-up period
- •Other medical conditions which in the opinion of the investigator would predispose the patient to poor wound healing, increased surgical risk, or poor compliance with the requirements of the study.
研究组 & 干预措施
RhinAer Stylus treatment
The RhinAer procedure will be performed in the study clinic using the RhinAer Stylus and Aerin Console. The RhinAer Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants will have both nostrils treated in the portion of the nasal cavity mucosa overlying the region of the posterior nasal nerve.
干预措施: RhinAer Stylus (Device)
结局指标
主要结局
Change in expression of nasal mucosal inflammatory markers in allergic and nonallergic chronic rhinitis patients
时间窗: Baseline and 3 months post study procedure
Change from baseline in expression of type-2 inflammatory cytokine markers in nasal mucus samples at 3 months post-procedure
次要结局
- The change in cough and post-nasal drip symptoms(From baseline to 6 months post-procedure)
- The change in nasal symptoms of chronic rhinitis(From baseline to 6 months post-procedure)
- Change in SNOT-22 score(From baseline to 6 months post-procedure)
- Evaluate the impact of the RhinAer treatment in subjects with migraine-related symptoms(From baseline to 6 months post-procedure)
- Evaluate medication usage in chronic rhinitis patients(From baseline to completion of study, an average of 6 months)
- Evaluate patient reported pain outcomes related to the study procedure(Completed following the study procedure during treatment visit)