The RhinAer Procedure for Treatment of CHronic RhInitis - A Prospective, MulticeNter Randomized ConTrolled TRial Comparing RhinAer to Sham Control (RHINTRAC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 25
- 主要终点
- Reflective Total Nasal Symptom Score (rTNSS) Responder Rate
研究概览
简要总结
The purpose of this study is to compare the RhinAer procedure with radiofrequency (RF) energy to sham procedure for treatment of chronic rhinitis.
详细描述
The purpose of this study is to compare the RhinAer procedure to treat tissue in the posterior nasal nerve area to improve symptoms in adults diagnosed with chronic rhinitis with a sham procedure that duplicates the actual procedure as closely as possible absent the delivery of radiofrequency (RF) energy to the nasal tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participant will be blinded to the study arm they are assigned to.
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
Reflective Total Nasal Symptom Score (rTNSS) Responder Rate
时间窗: 3 months visit following the study procedure.
TNSS is an instrument used to collect patient self-rated severity of nasal symptoms. 4 Symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) are reported with score of 0/absent; 1/mild; 2/moderate; 3/severe. The total score is the sum of the 4 nasal symptom scores with a maximum TNSS of 12 indicating the most severe symptoms. Treatment Responder based on rTNSS improvement Individual participant success (responder) is defined as at least 30% improvement (decrease) in the rTNSS from baseline. For this protocol patients had to meet inclusion criteria of rTNSS rating of 2 or 3 for Rhinorrhea; rTNSS rating of 1, 2 or 3 for Congestion; and total rTNSS score \>/= 6 at baseline
次要结局
- Percentage of Participants With Treatment Related Events (Safety)(At or following the study procedure up to to 3 months.)
- Reflective Total Nasal Symptom Score (rTNSS) Mean Change(Change from Baseline to 12 months following the study procedure.)