A Prospective, Open Label, Multi-Center Study Using the RhinAer Procedure for Treatment of Subjects Suffering With Chronic Rhinitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 试验地点
- 30
- 主要终点
- Mean Change of the Reflective Total Nasal Symptoms Score (rTNSS)
研究概览
简要总结
Post-market study to continue to evaluate the effectiveness of the RhinAer ARC Stylus for chronic rhinitis.
详细描述
Prospective, Open Label, Multicenter Study of the Aerin Medical RhinAer® ARC Stylus for Chronic Rhinitis to continue to evaluate the effectiveness of the RhinAer® ARC 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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 85 years (inclusively).
- •Willing and able to provide informed consent.
- •Willing and able to comply with the subject-specific requirements outlined in the Study Protocol.
- •Seeking treatment for chronic rhinitis symptoms of at least 6 months duration and willing to undergo an office-based procedure.
- •Moderate to severe symptoms of rhinorrhea (rTNSS rating of 2 or 3 for rhinorrhea).
- •Mild to severe symptoms of nasal congestion (rTNSS rating of 1, 2 or 3 for congestion).
排除标准
- •Anatomic obstructions that in the investigator's opinion limit access to the posterior nasal passage.
- •Altered anatomy of the posterior nose as a result of prior sinus or nasal surgery or injury.
- •Active nasal or sinus infection.
- •History of significant dry eye.
- •History of any of the following: chronic epistaxis, documented episodes of significant nose bleeds in the past 3 months, rhinitis medicamentosa, head or neck irradiation.
- •Have rhinitis symptoms only on a seasonal basis due to allergies.
- •Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure session.
- •Known or suspected to be pregnant or is lactating.
- •Participating in another clinical research study.
- •Has any condition that predisposes to excessive bleeding.
- •Is taking anticoagulants (eg, warfarin, Plavix) or 325 mg aspirin that cannot be discontinued before the procedure.
- •Has previous procedure or surgery for chronic rhinitis.
- •Other medical conditions which in the opinion of the investigator would predispose the subject to poor wound healing, increased surgical risk, or poor compliance with the requirements of the study.
结局指标
主要结局
Mean Change of the Reflective Total Nasal Symptoms Score (rTNSS)
时间窗: Baseline and 3 months post study procedure
The rTNSS (Total Nasal Symptom Score) is a brief questionnaire developed to assess the severity of symptoms in individuals with rhinitis, particularly allergic rhinitis The questionnaire consists of questions that evaluate the following 4 symptoms of Nasal Congestion, Runny Nose, Nasal Itching and Sneezing. Each symptom is rated on a 4-point scale from "0" (no symptoms), "1" (mild symptoms), "2" (moderate symptoms" and "3" (severe symptoms). The total score is calculated by summing up the individual scores for each symptom. The total score is the sum of the 4 nasal symptoms. A low score indicates lower symptoms, a higher score indicates more symptoms. Range of score is 0-12 This questionnaire was provided to subjects at baseline and again at 3 months post procedure. This outcome measure shows the difference in overall scores. The average change in the score between baseline and 3M
次要结局
- rTNSS Score at 6 Months(6 Months)
- 3 Month - Mean Change in Mini Rhinoconjuctivitis Quality of Life Questionnaire (Mini RQLQ)(Baseline and 3 months post study procedure)
- Participant Responder Percentage(Baseline and 3 months post study procedure)
- 6 Months - Mean Change in Mini Rhinoconjuctivitis Quality of Life Questionnaire (Mini RQLQ)(6 Months)
- Number of Participants With Device Related Adverse Events(Baseline and 3 months post study procedure)
- rTNSS Scores at 3 Months(3 Months)
- rTNSS Change From Baseline at 6 Months Post Procedure(6 Months)