TRX_2018_01 RETHINK REFLUX REGISTRY
Research type
Research Study
Full title
Research to further inform thinking about the role of LINX for Reflux Disease
IRAS ID
284163
Contact name
Nehra Dhiren
Contact email
Sponsor organisation
Ethicon Endo-Surgery, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
12 years, 6 months, 31 days
Research summary
This is a multi-centre, observational registry study that will follow patients for a total of 10 years from the date of their LINX Reflux Management System (the LINX device) implant in order to treat their Gastroesophageal Reflux Disease (GERD). As this is an observational study, taking part in the study does not change the care that the patient receives, their treatment or follow-up.\nThe LINX device is a medical device designed to help a weak valve stay closed and keep acid in the stomach. The LINX device is made from multiple magnetic beads placed close together in a row on metal wires. The beads pull apart and open when the patient swallows food or liquid, then the magnets come back together after swallowing to keep the valve closed. The LINX device is an implant that is intended to stay in the body permanently but it can be surgically removed if needed.\nIt is hoped that 500 patients throughout the world who have the LINX device implanted will be recruited to the registry study. This information will provide the Sponsor with more information on how safe and effective the LINX device is and the impact that GERD has on people’s lives.
REC name
North of Scotland Research Ethics Committee 1
REC reference
20/NS/0077
Date of REC Opinion
29 Jun 2020
REC opinion
Favourable Opinion