NCT01844336已完成不适用
PBASE System Idiopathic Rhinitis Clinical Investigation
Chordate Medical5 个研究点 分布在 1 个国家目标入组 208 人开始时间: 2013年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 208
- 试验地点
- 5
- 主要终点
- Change in total vasomotor rhinitis symptom score to visit 3
研究概览
简要总结
The purpose of this study is to evaluate the performance of the PBASE system, in terms of the efficacy of treatment in patients with idiopathic rhinitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with persistent (>12w) symptoms of idiopathic rhinitis dominated by nasal congestion (± secretion) for an average of at least 1 h per day for at least 5 days during a period of 14 days
- •Having nasal congestion as major symptom, and a nasal congestion score of at least 2 (scale 0-3)
- •Male or female 18 - 65 years
- •Judged by the Investigator as suitable for participation in the study without safety concerns based on medical history and physical examination.
- •Willing and able to provide written informed consent prior to participation in the clinical investigation
- •Willing and able to comply with all study related procedures
排除标准
- •Patients with Allergic rhinitis, demonstrated by either positive skin prick test, phadiatop or RAST
- •Ongoing respiratory tract infection including nasal cavity at inclusion (treatment visit 1)
- •Systemic steroid treatment less than 4 weeks before the inclusion in the study
- •Patients with a history of nasal surgery like: septoplasty, cosmetic surgery, conchal surgery or any other nasal surgery except closed reposition for nasal fracture
- •History of frequent nose bleeds or a condition that increases the risk of excessive bleeding
- •Pronounced anterior septal deviation or other significant nasal pathology at endoscopic examination
- •Current malignancy of any kind
- •Known allergy to polyvinylchloride or medicinal liquid paraffin
- •Any disease, condition (medical or surgical) which, in the opinion of the investigator, might compromise the study results, or would place the subject at increased risk.
- •Any implant with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, defibrillator, vagal neurostimulator, deep brain stimulation, spinal stimulator, bone growth stimulator, or cochlear implant or any other implant in the head-, and neck region.
- •Previous treated with radiation on the face, head or neck regions
- •Female patients who are pregnant or nursing, or become pregnant at any time from inclusion of the study until end of the 8 week follow-up visit
- •Female patients: unwilling to use adequate contraceptive from the signing of the informed consent until end of the 8 week follow-up visit
- •Received study drug in a clinical trial for an investigational drug within the previous 30 days, or 5 half-lives, whichever is longer
结局指标
主要结局
Change in total vasomotor rhinitis symptom score to visit 3
时间窗: From baseline to 28 days after treatment visit 1
次要结局
未报告次要终点
研究者
研究点 (5)
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