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    Interventional procedure overview of laparoscopic insertion of a magnetic ring for gastro-oesophageal reflux disease

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    Additional information considered by IPAC

    Professional experts' opinions

    Expert advice was sought from consultants who have been nominated or ratified by their professional Society or Royal College. The advice received is their individual opinion and is not intended to represent the view of the society. The advice provided by professional experts, in the form of the completed questionnaires, is normally published in full on the NICE website during public consultation, except in circumstances but not limited to, when comments are considered voluminous, or publication would be unlawful or inappropriate.

    Five professional expert questionnaires for laparoscopic insertion of a magnetic ring for gastro-oesophageal reflux disease were submitted and can be found on the NICE website.

    Patient opinions

    One patient organisation submission for laparoscopic insertion of a magnetic ring for GORD was received and can be found on the NICE website. For patient commentators' opinions, 2 completed questionnaires were received.

    Company engagement

    A structured information request was sent to 1 company who manufacture a potentially relevant device for use in this procedure. NICE received 1 completed submission. This was considered by the IP team and any relevant points have been taken into consideration when preparing this overview.

    Issues for consideration by IPAC

    Ongoing trials:

    • A Post-Approval Study of the LINX® Reflux Management System (NCT01940185); observational cohort study; US; estimated enrolment n=200; estimated study completion date October 2025.

    • LINX Reflux Management System or Fundoplication Clinical Study in Patients with Hiatal Hernia >3 cm (NCT04695171); observational cohort study (patient registry); US; estimated enrolment n=450; estimated study completion date January 2028.

    • RETHINK REFLUX Registry (NCT04253392); observation study (patient registry); US, Austria, Germany, Italy, Singapore, UK; estimated enrolment n=500; estimated study completion date July 2032.

    • Registry of Outcomes from AntiReflux Surgery (ROARS) (NCT02923362); observation cohort study (patient registry); US; estimated enrolment n=2,500; estimated study completion date May 2025.