Children who suffer from painful constipation will soon be offered a new way of diagnosing and managing their condition, thanks to an agreement struck between Nottingham University Hospitals NHS Trust (NUH) and medical device manufacturer JEB Technologies.
The agreement means that technology developed through the MAGIC clinical research trial led by Professor Luca Marciani and funded by the National Institute for Health Research (NIHR) will become available to healthcare providers in the UK and worldwide.
Professor Marciani, professor of gastrointestinal imaging at the University of Nottingham, and the principal investigator of the MAGIC (MAGnetic resonance Imaging in paediatric Constipation) research programme, which started in Nottingham in 2015, said the agreement to allow commercial manufacturing was “wonderful news.”
He said: “This milestone has been a long time in the making and our TransiCap capsules innovation has been designed by children for children, in partnership with researchers and clinicians at NUH and the University of Nottingham.
“We have worked in partnership with the manufacturers throughout our research; in order to investigate a better managed and safer alternative to an old diagnostic test that involved the use of harmful radiation and this will help managing the problem of childhood constipation.”
The TransiCap capsules, which are smaller than Tic Tac sweets, once ingested travel along the gastrointestinal tract and allow physicians and researchers to track the progress of food through a patient’s digestive system, which show up on harmless MRI scans. They will be used in the treatment of childhood constipation; a serious gastroenterological condition suffered by one in 10 children and young people and which becomes chronic in a third of patients.
An estimated 600,000 children go to their GP with this problem annually and at least 27,500 children are admitted to hospital with childhood constipation in England alone every year.
JEB Technologies is gearing up towards launching large scale production of new TransiCap MRI capsules.
The company has recently invested in installing a second low volume manufacturing line for initial production of these novel capsules, which children and young people will swallow, enabling the passage of the capsules through their gut to be tracked and measured using MRI scans.
Further clinical trials have been planned, to prove that this novel diagnostic method will allow their constipation to be better managed, and avoid the need for children and young people to have X-Rays, which expose them to potentially harmful radiation.
A group of children from the Young Person’s Advisory Group (YPAG) based in Nottingham have worked closely with Professor Marciani on ‘MAGIC’ throughout the project’s lifespan.
Olivia Ibbotson, one of the YPAG volunteers, said: “The agreement is a huge benefit to patients as it means they are able to get a quicker diagnosis and the correct management of the condition, which is urgently needed for young people suffering from constipation, as it affects their everyday life.
“Being involved in the 'MAGIC' research project through YPAG has been an amazing opportunity to be part of the processes the whole way through from designing the packing to being able to present at conferences with Professor Marciani. It's important as we are able to make sure the study is child-friendly, giving input on how the patient may feel from the view of a young person.”
Subject to gaining CE marking approval and other regulatory approval, which is being sought by JEB Technologies, the novel plastic capsules will be available as a healthcare product that can be used by gastroenterologists in their practice. Its trademarked name will be TransiCap.
The aim is to gain wide adoption for this method of diagnosis and monitoring of paediatric constipation within NHS clinical practice.
Sean Licence, head of medical devices at JEB Technologies said: “We are delighted to sign this agreement with Nottingham University Hospitals Research & Innovation which will enable the new TransiCap MRI capsules to enter commercial production – which will help many children with this serious gastrointestinal condition.
“As a company, JEB has been involved in manufacturing several innovative products over the years. We first became involved in the development process of these capsules when we were first asked to advance their initial design along with building a low volume manufacturing process.
“As well as fully funding the development, regulatory approval, and supply of product for clinical investigation, JEB has also invested in two low volume manufacturing lines. Once the device has started to establish itself on the market, our future plans are to grow the manufacturing lines to fully automate high volume systems.
“The reason JEB was happy to fund the development of this product, is that we believe it has great potential to make a very positive worldwide impact on this group of patients.”
