Taking TransiCap to market (MAGIC3)

Background Functional constipation affects 10% of children and young people, and 8% of adults. Management of these patients is challenging and based primarily on symptom reports. An objective measure of gut transit time could assist in directing therapy.

Since the 1980s, X-ray radiopaque markers (ROMs) methods have been available, but they provide an ionising radiation dose and are unable to define the colon anatomy well. Magnetic resonance imaging (MRI) can offer a new and better alternative.

Previous MAGIC (MAGnetic resonance Imaging in Constipation) projects Funded by 2 NIHR i4i grants, we developed strong PPIE and SME partnerships. We designed and manufactured novel mini-capsules devices to measure gut transit time using MRI. They are small (8mm×4mm) and made of inert biocompatible plastic material.

They are filled with an oil/water emulsion which provides a unique MRI signature. This allows to image the position of the mini-capsules in the body and, in turn, to assess gut transit.

We protected the core technology with a patent granted in 8 countries and the device name “TransiCap” with an international trade mark registration. We then carried out a feasibility study in children and young patients which was successful.

New MAGIC3 project This 3-years project is supported by 2 PPIE applicants, advisory groups, 2 universities, 3 hospitals, a clinical trials unit, 2 SMEs and 5 NIHR-funded infrastructures; building on the previous work, we will complete the MAGIC programme by: Ensuring that the research remains patient centred Simplifying the diagnostic test from two to a single MRI scan visit, thus also reducing its cost Extending the intended population for the device, originally developed for paediatrics, to patients with constipation of all ages above 7-years old Gathering Clinical Investigation data from 75 patients with constipation from 3 hospitals, and the human factors engineering data needed for the UKCA/CE marking applications, and submitting them Integrating and automating TransiCap image analysis and reporting within the Motilent software platform Progressing the family of patents with new intellectual property and territories Assessing the health economic benefit of using TransiCap and its Value Proposition.

Planning for adoption in the NHS and commercialisation, exploiting the Commercialisation Agreement already established with the manufacturer JEB Technologies Impact and Dissemination A new MRI diagnostic test of slow transit constipation, providing an objective measure of whole gut transit time and high quality images of the colon-rectum, available early in the clinical pathway will help to explain to the patients their gut problems and to guide therapy decisions.

This in turn will save NHS money by reducing repeated consultations, trial and error treatments and will increase patient satisfaction. This work will drive new clinical guidelines and pathways. We will engage cross-disciplinary academic audiences using presentations and publications to increase reach.

We will co-develop public events such as Imaging Discovery Days and showcases, reaching out not only to patients, carers and clinicians, but also to some of the local inner city socio-economically deprived and ethnically diverse communities.