On 4 May 2022, a hybrid kick-off meeting took place for the eCAP project: recipient of a €4.7 million grant from the European Union’s Research and Innovation Programme Horizon Europe. The aim of the project is to deliver a novel medical device combining a smart capsule with an e-health platform to enable better diagnostics, patient empowered disease management and hence, improved outcomes for patients with gastrointestinal (GI) diseases, a major source of population morbidity and care costs worldwide. The consortium, composed of 10 partners from research organisations and industry across Europe and Kenya, will demonstrate the universality of the eCAP solution in clinical trials in France as well as low resource environments by bringing the device to patients who so far have had limited access to GI disease diagnostics.

GI diseases, which range from functional problems to cancers, are among the most common medical ailments across the globe. Gastroesophageal reflux disease (GERD) alone affects an estimated 1.2 billion people globally, with prevalence growing in all regions of the world. Many GI diseases are difficult to diagnose as the symptoms are often vague and variable. Moreover, currently available diagnostics requires highly skilled interpretation and high set-up cost, leading to a dramatic lack of access. For instance, GERD is subject to definitive diagnostic testing in less than 2% of cases.

eCAP enabled diagnostics of GI disease

The eCAP consortium will develop a smart multi-sensing capsule, implanted by minimally invasive techniques, that enables GI physiology monitoring for a controlled period of time. Using ubiquitous smartphone communication standards and cloud computing, real-time patient experience data will be collected through an interactive user-friendly application. Patient-empowered disease management will be supported by accurate interpretation of the data by physicians, aided by Artificial Intelligence. “More accurate, cost-effective, patient-friendly testing for acid reflux is an increasingly urgent need today that the current solutions out on the market do not meet. I think the exciting thing is that this particular group of partners is uniquely suited to getting together to solve the problem of GI diseases affecting people worldwide”, explains Lee Swanström, Project Coordinator from the IHU Strasbourg. “As we began discussions, we had great ideas for expanding the initial proof of concept, even beyond GERD testing, so the project has enormous potential. We certainly thank the European community for recognizing our vision and supporting this project.”

eCAP will run for four years and draw on world-class expertise. The project is led by the Institute of Image-Guided Surgery of Strasbourg (FR). Technical solutions will be developed by Tyndall National Institute (IE), Sentron Europe BV (NL), Integer (IE) and Enterasense (IE), based on the user design input from Imagination Factory (UK). Clinical studies in Kenya and Ukraine will be conducted by Operating Theatre Practitioners Association of Kenya (OTPAK, KE) and a gastroenterology and endoscopy clinic in Kyiv – Olymed (UA), which continues to be actively involved in the project, despite the devastating hurdles they are undergoing today. Health economic analysis will be undertaken by Betthera (CZ) and project management and dissemination activities by AMIRES, The Business Innovation Management Institute (CZ).

Project consortium:

Project duration: 1 May 2022 – 30 April 2026

Press contacts: 

– Lee Swanström (Project Coordinator) lee.swanstrom@localhost

– Kristin Saar (Project Manager) saar@amires.eu

The University Hospital Institute (IHU) of Strasbourg has become the first French facility to obtain recognition of compliance with good laboratory practice for the preclinical evaluation of medical devices.

Operating room of the experimental platform at the IHU Strasbourg © IHU Strasbourg

Recognition by the ANSM

On October 21, following over two years of work, the French National Agency for the Safety of Medicines and Health Products (ANSM) awarded the Image-Guided Surgery Institute of Strasbourg recognition of compliance with Good Laboratory Practices. This recognition concerns implantable medical devices (vascular or digestive stents, surgical clips, prostheses) and diagnostic or treatment assistance devices, both hardware and software, including systems based on Artificial Intelligence.

The IHU in Strasbourg is the first academic institute in France, and one of the very first in Europe to obtain this recognition.

A guarantee for Industry

Certification of GLP compliance sets the IHU of Strasbourg apart from its peers for industry partners and collaborators. It allows them to simplify and accelerate their own accreditation processes, but also to test products before they are approved. Valid on the European market (CE marking), but also in all OECD member countries including the USA (FDA) and Japan, the accreditation represents the Industry’s confidence in trusting the IHU’s preclinical expertise.

An experimental platform and network of experts that are unique in the world

The IHU’s experimental platform is fitted with cutting-edge equipment in the fields of surgery, imaging, and minimally invasive therapies (flexible endoscopy, endovascular or percutaneous treatments, robot-assisted surgery). Since its creation, over fifty industry or academic laboratory professionals have been able to work in this platform in a wide range of fields, from hepato-gastroenterology, to cardiovascular studies, neurology and neurosurgery, as well as urology, interventional pneumology, thoracic surgery, gynaecology, and orthopaedics. By coming to the IHU in Strasbourg, manufacturers benefit from the expertise and tailor-made services of an internationally recognized research institute to test and verify the safety and expected effectiveness of their medical devices.

According to IHU Director, Benoît Gallix, “The recognition of GLP compliance should enable us to double this contracted research for industry professionals within two years”.

Customized services to meet the needs of the market

We provide tailor-made services to meet the needs of our customers. We accompany them from the preparation of their research plan by advising them on the experiments most suited to meeting their objectives and go as far as providing them with a complete report that can include a file for submissions to regulatory authorities.

Our experts are personally involved in these studies so as to contribute their knowledge and expertise and may also participate in the improvement of the product or the procedure thanks to their experience feedback.

The services we offer also apply to the organization of training sessions with industrial customers to train practitioners in the use of a new medical device or a new therapeutic approach. More particularly, we have a catalogue of preclinical in vivo and ex vivo models that we can adapt to the needs of our customers (catalogue provided on request) for a tailor-made course, adapted to the specificities of the device.

Download the brochure of the experimental platform

Read the press release – 08/11/2021 by Noiizy