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

NCT ID: NCT02136043

Last Updated: 2015-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-05-31

Brief Summary

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.

Conditions

Non-allergic Rhinitis.

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

Insertion of catheter into nasal cavity carried out by patient. Fixation of catheter during treatment with patient´s hand.

Group Type: EXPERIMENTAL

PBASE system 1.1 (active treatment)

Intervention Type: DEVICE

Group 2

Insertion of catheter into nasal cavity carried out by health professional. Fixation of catheter during treatment with helmet.

Group Type: EXPERIMENTAL

PBASE system 1.1 (active treatment)

Intervention Type: DEVICE

Interventions

PBASE system 1.1 (active treatment)

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Halmstad County Hospital

OTHER

Sponsor Role: lead

Responsible Party

Finn Jorgensen

Finn Jorgensen, M.D., Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Finn Jorgensen, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Halmstad County Hospital

Locations

Ear, Nose and Throat Dept, Halmstad County Hospital

Halmstad, , Sweden

Countries

Sweden

Other Identifiers

AHC14.

Identifier Type: -

Identifier Source: org_study_id