Periodic Reporting for period 1 - eCAP (eCAP - Ehealth CAPsule for digestive disease diagnostics and therapy)
Okres sprawozdawczy: 2022-05-01 do 2023-10-31
Gastrointestinal (GI) digestive diseases (GID), which range from functional problems to cancers, are among the most common medical ailments and represent a major source of population morbidity and care costs worldwide. GI diseases kill more than 200,000 EU citizens every year and are one of the most common reasons for primary care consultations and hospitalization. Their accurate and cost-effective diagnosis is essential for delivering evidence-based effective care and achieving optimal therapy and patient outcomes. Most GI diseases, however, are difficult to accurately or timely diagnose as the symptoms are often vague and variable, the digestive tract is difficult to access, and many GID are physiological processes that are not visible or reachable endoscopically and which may occur only episodically. In these cases, precise and timely diagnosis requires extended ambulatory monitoring of internal digestive functions with advanced techniques (e.g. manometry, pH testing or GI bleeding), which today is performed by crude analogue devices which require patients to have tubes in place through the nose and are tolerable only for a short time, resulting in loss of accuracy and physician and patient acceptance.
GERD is subject to accurate diagnostics to enable appropriate management in less than 2% of cases. Currently available diagnostics have high set-up cost and need highly skilled interpretation which largely puts them out of reach to the average healthcare practitioner which results in a dramatic lack of access (Less than 10% of French GERD sufferers are tested and there is no pH ambulatory testing in all of Ukraine for example). Another barrier to correcting this is the primitive level of technology available today which involves cumbersome workflow with multiple visits to clinical facilities, poor accuracy and patient compliance. Current solutions are passive and not designed to truly empower patient input. Advances in microelectronics and optics that have made capsule endoscopy more common have not to date been extended to ambulatory diagnostics and are themselves not yet optimized.
eCAP project aims to improve GERD diagnostics via smart multi-sensing capsule-based data collection combined with real time patient experience data – collected by interactive patient-oriented smartphone applications. The data will be collated and analysed by cloud-based computations, which are transmitted in a secure and interpretable fashion to caregivers and patients. All with the intention of achieving improved access to care, active patient engagement and personalized and evidence-based medicine.
The eCAP project is centred around the fusion of
i) Advanced capsule technology
ii) Minimally invasive and controllable implantation for targeted and longitudinal evaluation of digestive physiology,
iii) Full integration to a digital health platform, to allow dissemination of this leap in GI diagnostics to patients and doctors worldwide, including in low-resource environments.
Our novel solution is a multi-sensor capsule with direct link by universally available Bluetooth communication, implanted by a minimally invasive procedure, linked to a smartphone application customized for personalised diagnosis and therapy, with data processing by cloud-based algorithms to improve workflow and accuracy.
The objectives of the project are:
- Performing an extended user design and specification analysis, with experts in the field in France, Ukraine and Kenya.
- Creation of a novel smart GI capsule that contains multiple sensors to detect a variety of biochemical and physiologic events associated with GI disorders.
- Integrating the capsule with an e-health platform that will facilitate result interpretation.
- Validating the eCAP technology in patients suffering from gastroesophageal reflux disease in different clinical settings (France, Ukraine and Kenya) and assessing the economic impact via cost-effective analysis.
GERD is subject to accurate diagnostics to enable appropriate management in less than 2% of cases. Currently available diagnostics have high set-up cost and need highly skilled interpretation which largely puts them out of reach to the average healthcare practitioner which results in a dramatic lack of access (Less than 10% of French GERD sufferers are tested and there is no pH ambulatory testing in all of Ukraine for example). Another barrier to correcting this is the primitive level of technology available today which involves cumbersome workflow with multiple visits to clinical facilities, poor accuracy and patient compliance. Current solutions are passive and not designed to truly empower patient input. Advances in microelectronics and optics that have made capsule endoscopy more common have not to date been extended to ambulatory diagnostics and are themselves not yet optimized.
eCAP project aims to improve GERD diagnostics via smart multi-sensing capsule-based data collection combined with real time patient experience data – collected by interactive patient-oriented smartphone applications. The data will be collated and analysed by cloud-based computations, which are transmitted in a secure and interpretable fashion to caregivers and patients. All with the intention of achieving improved access to care, active patient engagement and personalized and evidence-based medicine.
The eCAP project is centred around the fusion of
i) Advanced capsule technology
ii) Minimally invasive and controllable implantation for targeted and longitudinal evaluation of digestive physiology,
iii) Full integration to a digital health platform, to allow dissemination of this leap in GI diagnostics to patients and doctors worldwide, including in low-resource environments.
Our novel solution is a multi-sensor capsule with direct link by universally available Bluetooth communication, implanted by a minimally invasive procedure, linked to a smartphone application customized for personalised diagnosis and therapy, with data processing by cloud-based algorithms to improve workflow and accuracy.
The objectives of the project are:
- Performing an extended user design and specification analysis, with experts in the field in France, Ukraine and Kenya.
- Creation of a novel smart GI capsule that contains multiple sensors to detect a variety of biochemical and physiologic events associated with GI disorders.
- Integrating the capsule with an e-health platform that will facilitate result interpretation.
- Validating the eCAP technology in patients suffering from gastroesophageal reflux disease in different clinical settings (France, Ukraine and Kenya) and assessing the economic impact via cost-effective analysis.
To date, human-centred design research has been undertaken to understand stakeholder needs and desires for the design of the new eCAP smart multi-sensing capsule and the associated e-health platform. The network of stakeholders central to the success of the project has been identified by patient journey mapping and stakeholder mapping exercises. Based on this, key stakeholder groups were interviewed to gain insight into their role in the diagnostic procedure, pain points with current systems, and opportunity for improvement. The research has identified considerable benefits to capsule tests as opposed to the catheter pH test. Initial regulatory strategy planning and health economics analysis has been completed.
Prototyping is also moving along: power profiling, as well as development of sensors, battery, antenna, delivery device and miniaturisation have taken place. Test benches have been developed and first prototypes are undergoing unit testing.
Delivery device and antenna has already proved to be working during preclinical testing. Additional development and testing is planned and integration testing will take place during the coming months.
Work is also ongoing on the eHealth platform, and first elements of the different interfaces have been developed. We also developed a full workflow analysis, covering wide range of aspects of the device, from usage, to manufacturing and packaging.
The current design is less dependent on big hospital infrastructure, and we believe that the design, thanks to the human centred approach will be suitable for low resource healthcare environments.
Prototyping is also moving along: power profiling, as well as development of sensors, battery, antenna, delivery device and miniaturisation have taken place. Test benches have been developed and first prototypes are undergoing unit testing.
Delivery device and antenna has already proved to be working during preclinical testing. Additional development and testing is planned and integration testing will take place during the coming months.
Work is also ongoing on the eHealth platform, and first elements of the different interfaces have been developed. We also developed a full workflow analysis, covering wide range of aspects of the device, from usage, to manufacturing and packaging.
The current design is less dependent on big hospital infrastructure, and we believe that the design, thanks to the human centred approach will be suitable for low resource healthcare environments.
The capsule design currently includes several sensors giving unique insight for GERD diagnostics that have never been tested, coupled with patient reported outcome that can be correlated with the data collected by the capsule. Potentially pushing the boundaries of GERD diagnostic. The new ergonomic delivery device is also a promising change to the procedure and opening the GERD diagnosis to broader groups of countries by simplifying the delivery and relying less on costly infrastructures.