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PBASE System Idiopathic Rhinitis Clinical Investigation | Clinical Trials | Clareo Health

COMPLETEDNA

PBASE System Idiopathic Rhinitis Clinical Investigation

NCT01844336•Chordate Medical

Summary

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.

Eligibility

Age

18 - 65 years

Sex

ALL

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.
+4 more criteria

Locations (5)

Falun, Sweden

Gothenburg, Sweden

Lund, Sweden

Stockholm, Sweden

Västerås, Sweden

Key Dates

Primary Completion Date

August 1, 2014

Last Updated

September 9, 2014

Enrollment

208

ACTUAL participants

Conditions

Idiopathic Rhinitis

Interventions

PBASE system 1.1 + CT100 (active treatment)

DEVICE

PBASE system 1.1 + CT100 (placebo treatment)

DEVICE

Posterior Nasal Nerve Combined with Anterior Ethmoid Neurotomy for Idiopathic Rhinitis

NCT06870292

Idiopathic Rhinitis

View study

COMPLETEDPHASE4

Neuro-immunological Analysis of Idiopathic Rhinitis Patients and Controls Treated With Capsaicin.

NCT01223820

Idiopathic Rhinitis PatientsHealthy Controls

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 9, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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