Clinical Evaluation of Safety and Efficacy for the ClariFix™ Cryotherapy Device in Subjects With Chronic Rhinitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 12
- 主要终点
- Device- and/or Procedure-related Serious Adverse Events
研究概览
简要总结
A multi-center, prospective, non-randomized, interventional clinical trial to assess the safety and effectiveness of the ClariFix™ device when used to ablate unwanted tissue in the nose of 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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is >21 years of age
- •Subject has moderate to severe symptoms of rhinorrhea (individual symptom rating of 2 or 3), mild to severe symptoms of congestion (individual symptom rating of 1, 2 or 3) and a minimum TNSS score of 4 (out of 12) at the time of the treatment visit, which have been present for > 6 months.
- •Subject has had documented allergy test within the last 10 years that defines whether or not subject has allergies to perennial and seasonal allergens or is willing to have one performed prior to study exit.
- •Subject has been dissatisfied with medical management, defined as usage of intranasal steroids for a minimum of 4 weeks without adequate symptom relief by the subject's assessment.
- •Subject has signed IRB-approved informed consent form
排除标准
- •Subject has clinically significant anatomic obstructions that in the investigator's opinion limit access to the posterior nose, including but not limited to septal deviation or perforation, nasal polyps, sinonasal tumor.
- •Subject has had any prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose.
- •Subject has active nasal or sinus infection.
- •Subject has moderate to severe ocular symptoms.
- •Subject has a history of nosebleeds in the past 3 months.
- •Subject has a history of rhinitis medicamentosa.
- •Subject has had prior head or neck irradiation
- •Subject has active coagulation disorder or is receiving anti-coagulants which cannot be safely stopped for 4 weeks (excluding aspirin).
- •Subject is pregnant.
- •Subject is participating in another clinical research study.
- •Subject has an allergy or intolerance to anesthetic agent.
- •Subject has cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, and/or, open and/or infected wounds at or near the target tissue.
- •Any physical condition that in the investigator's opinion would prevent adequate study participation or pose increased risk.
结局指标
主要结局
Device- and/or Procedure-related Serious Adverse Events
时间窗: 90 days post treatment
Safety will be evaluated based on the frequency of device- and/or procedure-related serious adverse events
Change From Baseline in Symptom Severity
时间窗: 90 days post treatment
Effectiveness will be assessed by the mean change in nasal symptoms using the 4-symptom rTNSS (reflective Total Nasal Symptom Score). The rTNSS is the sum of 4 individual patient-rated symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, and 3=Severe. The rTNSS has a possible score of 0-12. The reflective scores are based on the participant's evaluation of symptom severity over the preceding 24 hours. A change of 1 or more is considered the minimum clinically important difference.
次要结局
- Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)(90 days post treatment)