NL-OMON50568招募中不适用
A clinical investigation of Kinetic Oscillation Stimulation by the Chordate System S101 in the treatment of Non Allergic Rhinitis (KOSNAR) - Chordate System S101 Non Allergic Rhinitis Clinical Investigation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients with persistent (>12w) symptoms of non-allergic 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.
- •2. Having nasal congestion as major symptom, and a median nasal congestion
- •score of at least 2 (scale 0-3)
- •3. Male or female 18 * 65 years
- •4. Judged by the Investigator as suitable for participation in the study
- •without safety concerns based on medical history and physical examination.
- •5. Willing and able to provide written informed consent prior to participation
- •in the clinical investigation
- •6. 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 during the last year.
- •2. Ongoing respiratory tract infection including nasal cavity at inclusion
- •3. Systemic steroid treatment less than 4 weeks before the inclusion in the
- •4. Patients with a history of nasal surgery like: septoplasty, cosmetic
- •surgery, conchal surgery or any other nasal surgery except closed reposition
- •for nasal fracture during last year
- •5. History of frequent nose bleeds or a condition that increases the risk of
- •excessive bleeding
- •6. Pronounced anterior septal deviation or other significant nasal pathology at
- •endoscopic examination
- •7. Current malignancy of any kind
- •8. Known allergy to polyvinylchloride or medicinal liquid paraffin
- •9. Any disease, condition (medical or surgical) or drug or alcohol abuse which,
- •in the opinion of the investigator, might compromise the study results, or
- •would place the patient at increased risk.
- •10. 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.
- •11. Previous treated with radiation on the face, head or neck regions
- •12. Female patients who are pregnant or become pregnant at any time from
- •inclusion of the study until end of the 8 week follow-up visit
- •13. Received study drug in a clinical trial for an investigational drug within
- •the previous 30 days, or 5 half-lives, whichever is longer
研究者
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