PBASE System Idiopathic Rhinitis Clinical Investigation

Study Overview
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Brief Summary
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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.

Conditions
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Idiopathic Rhinitis

Intervention / Treatment
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* Device: PBASE system 1.1 + CT100 (active treatment)
* Device: PBASE system 1.1 + CT100 (placebo treatment)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PBASE system 1.1 + CT100 (active treatment)<br> | Device: PBASE system 1.1 + CT100 (active treatment)<br> <br> |
| Placebo Comparator: PBASE system 1.1 + CT100 (placebo treatment)<br> | Device: PBASE system 1.1 + CT100 (placebo treatment)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total vasomotor rhinitis symptom score to visit 3 |  | From baseline to 28 days after treatment visit 1 |