Paris, France - Predict4Health announced today that the first patient has been enrolled in the CIBIL clinical trial “Clinical Impact of the iBox as an early Intervention tool”. A prospective randomized controlled trial to assess the use of a software predicting allograft survival in the follow-up of kidney transplanted patients (NCT05112315). This marks the beginning of this first-of-its-kind clinical trial conducted in Europe evaluating a digital health solution.
The CIBIL study aims to provide clinical and health economic evidence to allow further deployment of Predigraft in Europe. It opens the way to a large adoption of AI-based medical device softwares.
Predigraft is a CE-marked class IIa medical device under MDR 2017/745, offering physicians and hospitals an easy-to-use platform that simplifies access to data and decision making. Predigraft embeds the iBox algorithm, a unique AI-based technology predicting individual long term kidney allograft survival.
“We are excited to start recruitment in the CIBIL study”, stated Professor Carmen Lefaucheur, transplant nephrologist at Saint-Louis Hospital. ”Following promising preliminary results, we are now looking forward to seeing the clinical benefits of using the iBox as an early intervention monitoring tool for kidney transplanted patients”, continued Professor Alexandre Loupy, Head of the Paris Transplant Group.
Predigraft: Predigraft was created based on the iBox technology, an algorithm developed by the Paris Transplant Group (INSERM UMR 970 / AP-HP / University of Paris), which gives the probability that the graft will still be functional at 3, 5 and 7 years after evaluation by the healthcare professional.
About Predict4Health: Predict4Health is a pioneer in the development of artificial intelligence-based software medical devices, offering its solutions to patients, healthcare professionals and to the pharmaceutical industry. Predict4Health's ambition is to build the distribution platform for algorithms to prevent organ failures. Predict4Health's expertise in the regulatory, clinical and infrastructure aspects of digital health solutions places it in a unique position to achieve this goal.