ClariFix Rhinitis Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 2
- 主要终点
- rTNSS Responder Rate
研究概览
简要总结
A randomized, sham-controlled, single-blind study of cryotherapy as a treatment for chronic rhinitis.
详细描述
A prospective, multicenter, randomized, sham-controlled, single-blind (participants) study to demonstrate the superiority of treatment with the ClariFix cryotherapy device for reducing symptoms when compared with a sham treatment in patients with chronic rhinitis. The ClariFix device is a Class II FDA-cleared medical device that is intended to be used as a cryosurgical tool for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.
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
All participants will be blinded to treatment assignment from procedure through their 90-day visit.
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
- •Be ≥21 years of age.
- •Has been diagnosed with chronic nonallergic or allergic rhinitis.
- •Have moderate to severe symptoms of rhinorrhea (individual reflective Total Nasal Symptoms Score [rTNSS] symptom rating of 2 or 3), mild to severe symptoms of nasal congestion (individual rTNSS symptom rating of 1, 2, or 3), and a minimum total rTNSS of 4 (out of 12) at baseline.
- •Have an allergy test (by skin prick or intradermal testing or by validated in vitro tests for specific Immunoglobin E [IgE]) on file within 12 months of the baseline visit.
- •Be an appropriate candidate for bilateral ClariFix treatment performed under local anesthesia.
- •Be willing and able to comply with all study elements, as indicated by their written informed consent.
- •Be willing and able to comply with all study elements and provide written consent.
排除标准
- •Have clinically significant anatomic obstructions that in the investigator's opinion limit access to the posterior nose, including but not limited to severe septal deviation or perforation, nasal polyps, and/or sinonasal tumor.
- •Have had previous sinus or nasal surgery within 6 months of study enrollment.
- •Have previously undergone cryotherapy or other surgical interventions for rhinitis.
- •Have an active nasal or sinus infection.
- •Have rhinitis symptoms that are primarily due to seasonal allergies.
- •Have plans to (or otherwise anticipates the need to) undergo an ENT (ear, nose, throat) procedure concurrently or within 3 months after the study procedure.
- •Is on prescribed anticoagulants (eg, warfarin, Plavix) or 325 mg aspirin that cannot be discontinued before the procedure (81 mg aspirin and herbal supplements are acceptable).
- •Be unable to discontinue ipratropium bromide (IB) at least 14 days before baseline and through the 90-day follow-up visit.
- •Have a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months.
- •Have a history of rhinitis medicamentosa.
- •Have had previous head and/or neck irradiation.
- •Have an allergy or intolerance to local anesthetic agents.
- •Have cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, and/or open and/or infected wounds at or near the target tissue.
- •Have a neurological, medical, psychiatric condition, or social circumstance that would potentially increase risk, interfere with study participation, or confound interpretation of study data.
- •Be participating in another clinical research study.
结局指标
主要结局
rTNSS Responder Rate
时间窗: 90-days post treatment
Responders are defined as participants with a 30% or greater reduction in reflective Total Nasal Symptom Score (rTNSS) relative to baseline. The active treatment will be compared with the sham treatment. The reflective Total Nasal Symptom Score (rTNSS) is a validated PRO consisting of 4 nasal symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing that are assessed over the previous 2-week period. Each symptom is rated on a scale of 0 (no symptoms) to 3 (severe symptoms) and the scores are summed to provide a total rTNSS with a possible range of 0 to 12.
次要结局
- Patient Satisfaction Questionnaire(Through 12 months post treatment)
- Serious Device- and/or Procedure-related Adverse Events(Through 12 months post procedure)
- rTNSS Responder Rate(Through 12 months post treatment)
- Change in Total RQLQ(S)(Through 12 months post treatment)