Knowledge Unwrapped: Protocol for CLASSICA software as medical device trial

19. 9. 2025 / Project announcements New publication outlines the clinical trial evaluating CLASSICA-OR for real-time AI-supported cancer detection

he CLASSICA team has published “Protocol for CLASSICA software as medical device trial” in Minimally Invasive Therapy & Allied Technologies. The article, co-authored by Arctur researchers Jernej Čuček and Samo Eržen, details the design of the regulated clinical trial evaluating CLASSICA’s AI-driven system for detecting rectal cancer during surgery.

The study will enrol 127 patients across seven centres in five European countries, using fluorescence angiography (FA) and the CLASSICA-OR software to analyse real-time signals and guide targeted biopsies. Traditional biopsies and pathology will serve as the comparative standard.

This work builds on previous CLASSICA research showing that FA combined with AI can distinguish cancerous from benign tissue. The trial aims to determine whether the approach can improve diagnostic accuracy and support more informed surgical decision-making.

Recruitment is beginning following ethics and regulatory approval, with results to inform further optimisation and future medical device certification.