Status:
COMPLETED
Investigation of Kinetic Oscillation Stimulation by the Chordate System S101 in the Treatment of Non Allergic Rhinitis
Lead Sponsor:
Chordate Medical
Conditions:
Nasal Congestion
Non-allergic Rhinitis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This is an interventional, multicenter, double-blind, placebo-controlled trial in which patients diagnosed with non-allergic rhinitis will be randomized to either intranasal stimulation, or placebo tr...
Detailed Description
This is a double-blind, placebo-controlled, multi-center study in which patients diagnosed with non-allergic rhinitis will receive intranasal stimulation with the Chordate System at two occasions. Obj...
Eligibility Criteria
Inclusion
- 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.
- Having nasal congestion as major symptom, and a median 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
- Patients with Allergic rhinitis, demonstrated by either positive skin prick test, Phadiatop or RAST during the last year.
- Ongoing respiratory tract infection including nasal cavity at inclusion
- 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 during last year
- 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) 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.
- 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 become pregnant at any time from inclusion of the study 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
Key Trial Info
Start Date :
May 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
279 Patients enrolled
Trial Details
Trial ID
NCT03399721
Start Date
May 7 2018
End Date
September 30 2022
Last Update
September 22 2023
Active Locations (13)
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1
Charles University Faculty of Medicine in Hradec Králové
Hradec Králové, Czechia
2
Hospital Pardubice
Pardubice, Czechia
3
Charles University Motol University Hospital
Prague, Czechia
4
Helsinki University Hospital
Helsinki, Finland