PBASE System Idiopathic Rhinitis Clinical Investigation

Chordate Medical

Status

Completed

Conditions

Idiopathic Rhinitis

Treatments

Device: PBASE system 1.1 + CT100 (placebo treatment)

Device: PBASE system 1.1 + CT100 (active treatment)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01844336

PR003

Details and patient eligibility

About

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.

Enrollment

208 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 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