TransiCap MRI Visible Capsule Device / MAGIC 2

  • Research type

    Research Study

  • Full title

    A multicentre pragmatic clinical investigation to assess the efficacy of TransiCap MRI marker device in magnetic resonance imaging in paediatric constipation (MAGIC2)

  • IRAS ID

    272546

  • Contact name

    Luca Marciani

  • Contact email

    luca.marciani@nottingham.ac.uk

  • Sponsor organisation

    Nottingham University Hospitals NHS Trust

  • ISRCTN Number

    ISRCTN42273449

  • Duration of Study in the UK

    2 years, 6 months, 1 days

  • Research summary

    One in ten children worldwide has constipation and it becomes chronic in 30% of these children, affecting their and their families’ well-being. Managing these children is difficult, partly because it can be difficult to define the nature and cause of the problem. If the doctors could send the children for a quick test that indicates the time that food takes to travel through the gut (the “gut transit time”), they could use this information to help choose the best therapy, for example to decide if a patient needs surgery. The test could also be used to follow up the effects of different treatments. Gut transit time is often not tested due to the unsuitable radiation dose involved in the current methods such as X-ray. Doctors’ decisions have to rely mostly on symptoms, leading to repeated appointments, causing inconvenience for parents and children and loss of time from school and work, frustration with lack of effective treatments and consequently wasting valuable NHS resources.
    We have devised a new way to measure gut transit time using TransiCap capsules. These capsules are swallowed by the patient, and the capsules journey through the gut is captured using Magnetic Resonance Imaging (MRI). These images can be used to measure gut transit time by counting how many capsules appear in each image.
    We wish to use gut transit time measurements to inform a patient’s treatment, and measure whether informed treatment selection leads to treatment success at 12 months.

  • REC name

    West Midlands - Edgbaston Research Ethics Committee

  • REC reference

    20/WM/0040

  • Date of REC Opinion

    9 Apr 2020

  • REC opinion

    Further Information Favourable Opinion