New CLASSICA project publication
A new CLASSICA publication, “Protocol for CLASSICA software as medical device trial,” has been released in Minimally Invasive Therapy & Allied Technologies. The article, authored by a multidisciplinary team including Arctur’s Jernej Čuček and Samo Eržen, describes the regulated clinical trial that will evaluate CLASSICA’s real-time AI-powered decision support software for cancer detection during surgery.
The publication presents the background and clinical need: current methods for identifying rectal cancer before transanal excision remain limited. By combining fluorescence angiography (FA) with artificial intelligence, CLASSICA aims to enhance accuracy during intraoperative assessment.
Study design
The protocol outlines a multicentre, prospective diagnostic trial involving up to 127 patients across seven surgical centres in five European countries.
The study will validate a real-time AI-driven FA method for:
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in-situ digital detection of rectal cancer, and
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targeted endoscopic biopsy guidance.
Conventional biopsies and pathology serve as the comparative standard. The study design adheres to GDPR, Good Clinical Practice (GCP), and FAIR data principles, including requirements for secure pseudonymisation and trans-border data sharing.
Building on previous CLASSICA work
This phase follows earlier multicentre collaboration that recruited 130 patients and generated the foundational FA dataset (200 videos). Alongside the software, a secure online data-sharing environment and a clinical-grade medical device platform have been developed, and institutional approvals for the trial are underway.
Advancing CLASSICA-OR into the operating room
The publication marks a significant step: the CLASSICA-OR system will now be evaluated directly in the operating theatre as a regulated medical device, analysing FA data live to support digital biopsy decisions and indicate areas most suspicious for malignancy.
The full article is available through the CLASSICA Zenodo community.