Clinical Evaluation of Low Power Radiofrequency Energy Applied to the Posterior Nasal Nerve Area for Symptomatic Relief of Chronic Rhinitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 10
- 主要终点
- Percentage of Participants With Treatment Related Adverse Events (Safety)
研究概览
简要总结
Evaluation of the Aerin Medical Device used for the treatment of chronic rhinitis
详细描述
This is a non-significant risk, prospective, multi-center, non-randomized study to evaluate the safety and efficacy of the Aerin Medical device (InSeca Stylus) when used to deliver radiofrequency (RF) energy to the posterior nasal nerve area to improve symptoms in those 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 22 to 75 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)
- •rTNSS score of greater than or equal to 6
- •Dissatisfaction with medical management, defined as usage of intranasal steroids for a minimum of 4 weeks without adequate symptom relief, as judged by the subject
排除标准
- •Anatomic obstructions that in the investigator's opinion limit access to the posterior nose
- •Altered anatomy of the posterior nose as a result of prior sinus or nasal surgery or injury
- •Active nasal or sinus infection
- •Moderate to severe ocular allergic symptoms (such as eye tearing [epiphora], itching [pruritus], or redness [erythema])
- •History of significant dry eye
- •History of any of the following: nose bleeds in the past 3 months, rhinitis medicamentosa, head or neck irradiation
- •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
- •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
Percentage of Participants With Treatment Related Adverse Events (Safety)
时间窗: At or following the study procedure, and up to the final study visit at 1 year.
Characterization of the type and frequency of treatment-related adverse events reported during or following the study procedure. Subjects were asked about possible side effects or adverse experiences related to the study procedure at each follow up visit. Each event was documented and identified as to its relationship and level of relatedness to the study device and/or study procedure. This measure includes any subject who experienced at least one event considered definitely, probably, or possibly related to the device or procedure.
Change in Reflective Total Nasal Symptom Score (rTNSS)
时间窗: Comparison of scores at Baseline and 12 weeks post procedure
Mean change in Reflective Total Nasal Symptoms Score (rTNSS) from baseline to 12 weeks post-study procedure. Improvement (12 week score - baseline score) is signified by a negative value. The Reflective Total Nasal Symptom Score (rTNSS) is a patient self reported questionnaire of four nasal symptoms: rhinitis, nasal congestion, nasal itching and sneezing. Patients will report their symptoms reflected or felt over the last 12 hours. Total scores can range from 0 to 12. A higher score indicates increased symptom severity. This study will measure the mean change in the rTNSS total score from Baseline to 12 week follow up visit
次要结局
未报告次要终点