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Name:   A clinical investigation of Kinetic Oscillation by the Chordate System S101 in the treatment of Non Allergic Rhinitis

Acronym: KOSNAR

Summary & Eligibility:

The purpose of this study is to investigate if patients with symptoms of stuffiness in the nose without any allergy diagnosis (non-allergic rhinitis) will experience less problems after two treatment occasions with the medical device from Chordate Medical AB, called Chordate System S101. The treatment is performed with a small balloon attached to a tube. The balloon is inserted into the nasal cavity and a headband is used to hold the tube in place. The tube is then connected to the Chordate System S101 device. When the treatment starts the balloon is inflated and the mucous membrane of the nose is stimulated. The treatment time is 10 minutes in each nostril. After treatment, the balloon is removed along with the headband. The effectiveness of this device is measured using questionnaires, Peak Nasal Inhalation Flow (PNIF) response and a patient e-diary.

General Inclusion Criteria

  • Patients with persistent symptoms of non-allergic rhinitis dominated by nasal congestion for an average of at least 1 hour 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.

General Exclusion criteria

  • Patients with Allergic rhinitis.
  • Ongoing respiratory tract infection including nasal cavity at inclusion.
  • Systemic steroid treatment less than 4 weeks before inclusion in the study.
  • Patients with a history of nasal surgery.
  • 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.
  • Previously 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.

For full inclusion and exclusion criteria contact the InHANSE team.

Status: Pending

Sponsor: Chordate Medical

Study Coordinator:

Samantha Ballantyne
Senior Clinical Research Associate on behalf of:

www.linkmedical.no

Study Schema:

KOSNAR Trial Schema

 

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