Chordate System S101 Non Allergic Rhinitis Clinical Investigation
Research type
Research Study
Full title
A clinical investigation of Kinetic Oscillation Stimulation by the Chordate System S101 in the treatment of Non Allergic Rhinitis (KOSNAR)
IRAS ID
241347
Contact name
Claire Hopkins
Contact email
Sponsor organisation
Chordate Medical AB
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 8 months, 2 days
Research summary
This study is being conducted in subjects diagnosed with non-allergic rhinitis and suffering from problems with stuffiness in the nose. The purpose with this study is to investigate if patient with symptoms of stuffiness in the nose without any allergy diagnosis will experience less problems after two treatment occasions with the medical device from Chordate Medical AB, called Chordate System S101.
Approximately 300 subjects will take part in this study at 13 sites in 5 European countries. Participation will last about one year with a requirement to visit the clinic at least 6 times. Subject will receive treatment with S101 system twice within 4 weeks and will have to visit at 3, 6 and 12 months for follow up. During treatment subjects will sit in a chair. They will have a hair net over their hair and a headband placed on their head. The treatment is performed with a small balloon attached to a tube. The balloon is inserted into the nasal cavity and the headband is used to hold the tube in place. The tube will be 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 (total 20 minutes). After treatment, the balloon is removed along with the headband.
REC name
London - Stanmore Research Ethics Committee
REC reference
18/LO/0788
Date of REC Opinion
14 Aug 2018
REC opinion
Further Information Favourable Opinion