PM010 - Chordate system S220 Post Marketing study in Chronic Migraine
Research type
Research Study
Full title
An open Post-marketing Clinical Follow-up investigation to follow long-term performance and safety of intranasal kinetic oscillation in subjects with Chronic migraine
IRAS ID
315470
Contact name
Jan Hoffmann
Contact email
Sponsor organisation
Chordate Medical AB
Duration of Study in the UK
1 years, 10 months, 29 days
Research summary
This is an Open Post-marketing Clinical Follow-up of the use of the ChordateSystem S220. It will be conducted in 4 UK centres, 3 within the NHS hospitals and 1 in the National Migraine Institution. In addition it will be conducted in the following countries Italy, Germany and Israel. There will be 200 participants, with 50 being enrolled in the UK.
The study consists of a 4-week run-in period (baseline), a 6 week treatment period, and a 12-month follow-up period. 6 (six) treatments shall be given in the first 6 weeks and additional treatment, but not exceeding 14 treatments shall be given during the rest of the 12 months period in discussion with the participants doctor. Participants who provided written informed consent and are eligible for the study will be asked to complete a daily diary for the duration of the study. In the diary the participants will record headache and migraine days, any changes in their health, and concomitant medications they may be using.
The investigational medical device system is the Chordate System S220, which is used to stimulate human tissue inside the nasal cavities by means of kinetic oscillations at low frequencies. The Chordate System is CE-marked.REC name
West Midlands - Black Country Research Ethics Committee
REC reference
23/WM/0099
Date of REC Opinion
11 Aug 2023
REC opinion
Further Information Favourable Opinion