Periodic Reporting for period 1 - TELEGRAFT (Telemonitoring of home dialysis utilizing a smart biomimetic arteriovenous graft)
Periodo di rendicontazione: 2022-09-01 al 2024-02-29
With 10% of the worldwide population affected by chronic kidney disease and millions of deaths each year due to lack of access to healthcare treatment, there is a dire need for innovative and accessible devices which will help patients safely receive dialysis at home.
Through this international project, researchers and practitioners from eleven partner institutions across seven European countries seek to develop a revolutionary artificial blood vessel that is prevented from closing or becoming infected. The need is justified by the fact that up to 70% of current arteriovenous grafts fail in the first year after implantation. This is primarily due to thrombosis and infection. When using the new arteriovenous graft TeleGraft for dialysis, an artificial blood vessel can be used relatively easily and quickly for safe home dialysis and bypass surgery.
Solution:
TeleGraft stands for telemonitoring of home dialysis utilizing a smart biomimetic arteriovenous graft. It comprises two diagnostic tools to monitor and prevent device complication. Sound is used to monitor blood flow and optical sensors to detect inflammation and infections. The data is processed by AI machine learning models and displayed in an easy-to-understand dashboard on multiple platforms for healthcare professionals. The data will allow online telemonitoring as well as consultations by remote healthcare professionals. This makes home dialysis safe for patients, even in areas with poor infrastructure and where patients live far from hemodialysis clinics.
The TeleGraft system will be demonstrated in an operational environment through a 2-stage randomized clinical trial enrolling 60 patients at 5 hospitals across Europe (in Denmark, Sweden, Lithuania, Spain, and Germany) and through a home hemodialysis field study.
Through this international project, researchers and practitioners from eleven partner institutions across seven European countries seek to develop a revolutionary artificial blood vessel that is prevented from closing or becoming infected. The need is justified by the fact that up to 70% of current arteriovenous grafts fail in the first year after implantation. This is primarily due to thrombosis and infection. When using the new arteriovenous graft TeleGraft for dialysis, an artificial blood vessel can be used relatively easily and quickly for safe home dialysis and bypass surgery.
Solution:
TeleGraft stands for telemonitoring of home dialysis utilizing a smart biomimetic arteriovenous graft. It comprises two diagnostic tools to monitor and prevent device complication. Sound is used to monitor blood flow and optical sensors to detect inflammation and infections. The data is processed by AI machine learning models and displayed in an easy-to-understand dashboard on multiple platforms for healthcare professionals. The data will allow online telemonitoring as well as consultations by remote healthcare professionals. This makes home dialysis safe for patients, even in areas with poor infrastructure and where patients live far from hemodialysis clinics.
The TeleGraft system will be demonstrated in an operational environment through a 2-stage randomized clinical trial enrolling 60 patients at 5 hospitals across Europe (in Denmark, Sweden, Lithuania, Spain, and Germany) and through a home hemodialysis field study.
The arteriovenous graft function has been addressed and to this end, Biomodics (BM) has established a reactor to manufacture the grafts to be tested. The in-vivo aging test has been initiated as planned under the lead of Region Syddanmark (OUH) and the integration and performance are being monitored until removal of the grafts. In parallel, tissue integration is being tested by partner VERIGRAFT. In-vitro evaluations are also being conducted by Biomodics notably to test early cannulation and resistance to kinking. University of Birmingham (BHAM) is working towards establishing appropriate fluid dynamic modelling for simulations of blood flow in the graft.
The diagnostic tools and telemonitoring that will be developed in TeleGraft are being addressed by the partners Leibniz-Institut Fuer Photonische Technologien E.V (IPHT), OUH and BMD Software LDA (BMD). Under the lead of IPHT, the hardware for sensor and data collection is being analysed and the Raman spectrometer hardware is being developed. From this work and research, the standardization procedure is being developed for the analysis of the collected data and AI modeling. From these tasks, partner BMD is developing a data presentation software and easy to understand monitoring dashboard.
This work aims at preparing for the next phase of the project, the clinical evaluation of TeleGraft.
In addition, and as part of its communication and dissemination plan, the consortium has also been active in communication about the project, focusing on increasing its visibility towards its target audiences and partners at various events and online via its website and social media accounts. The exploitation plan of the project has been drafted and will frame the discussion on how the project´s results will be further utilized as TeleGraft and its component are being developed. Lastly, the regulatory pathway has been defined in its first version to prepare for the approval of TeleGraft when time comes.
The diagnostic tools and telemonitoring that will be developed in TeleGraft are being addressed by the partners Leibniz-Institut Fuer Photonische Technologien E.V (IPHT), OUH and BMD Software LDA (BMD). Under the lead of IPHT, the hardware for sensor and data collection is being analysed and the Raman spectrometer hardware is being developed. From this work and research, the standardization procedure is being developed for the analysis of the collected data and AI modeling. From these tasks, partner BMD is developing a data presentation software and easy to understand monitoring dashboard.
This work aims at preparing for the next phase of the project, the clinical evaluation of TeleGraft.
In addition, and as part of its communication and dissemination plan, the consortium has also been active in communication about the project, focusing on increasing its visibility towards its target audiences and partners at various events and online via its website and social media accounts. The exploitation plan of the project has been drafted and will frame the discussion on how the project´s results will be further utilized as TeleGraft and its component are being developed. Lastly, the regulatory pathway has been defined in its first version to prepare for the approval of TeleGraft when time comes.
In the longer term, the TeleGraft project is expected to be used for dialysis and to
• Improve performance of grafts for dialysis
• Enable more patients to receive dialysis at home
• Become a sustainable and affordable solution for smart active implants
• Allow for remote monitoring of complications and real-time online detection of potential device failures
• Allow transferal to bypass surgery
In low- and middle-income countries, TeleGraft will substitute complicated and expensive kidney transplantation and allow simpler and cheap implantation of arteriovenous graft for hemodialysis
• Improve performance of grafts for dialysis
• Enable more patients to receive dialysis at home
• Become a sustainable and affordable solution for smart active implants
• Allow for remote monitoring of complications and real-time online detection of potential device failures
• Allow transferal to bypass surgery
In low- and middle-income countries, TeleGraft will substitute complicated and expensive kidney transplantation and allow simpler and cheap implantation of arteriovenous graft for hemodialysis