PBASE System Idiopathic Rhinitis Clinical Investigation

Inclusion criteria

• 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

Exclusion criteria

• 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