Kinetic Oscillation Stimulation (KOS) of Nasal Mucosa in Non-allergic Rhinitis: Investigation of Treatment Procedure

Halmstad County Hospital

Status

Completed

Conditions

Non-allergic Rhinitis.

Treatments

Device: PBASE system 1.1 (active treatment)

Study type

Interventional

Funder types

Other

Identifiers

NCT02136043

AHC14.

Details and patient eligibility

About

The purpose of the study is to evaluate how treatment with Kinetic Oscillation Stimulation (KOS) in the nasal cavity in patients with non-allergic rhinitis can be optimized to minimize any patient reported discomfort during treatment procedure.

Enrollment

29 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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 procedure

Exclusion criteria

Patients with Allergic rhinitis, demonstrated by either positive skin prick test, phadiatop or RAST(radioallergosorbent test)
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 first visit at ENT(Ear, Nose and Throat) - clinic until treatment day (second visit)
Female patients: unwilling to use adequate contraceptive between first and last visit
Received study drug in a clinical trial for an investigational drug within the previous 30 days, or 5 half-lives, whichever is longer