The CLASSICA project is making substantial progress in the development and clinical validation of our AI-assisted surgical decision-support system. CLASSICA is now active across seven clinical sites in Ireland, Belgium, Austria, Italy, the Netherlands, and Greece. Clinical validation is structured around three studies that collectively assess the system in diverse surgical contexts.
Study 1 focuses on generalisability and usability and continues to collect intra-operative video data to develop and evaluate the system’s performance in varied clinical environments. To date, over 150 procedures have been annotated and analysed, enabling cross-site comparisons and iterative improvement of the AI models.
Study 2, an interventional trial investigating AI-guided biopsy in the OR, was launched at the Mater Misericordiae University Hospital in Dublin during this reporting period. The first patients have been successfully recruited, and the CLASSICA software has been deployed for use in live procedures.
Study 3, which will evaluate AI-assisted resection, remains in the preparatory phase, with updates to follow in the next reporting period.
Over the course of the project, the CLASSICA AI pipeline has been refined to improve tissue tracking, image enhancement, and fluorescence-based classification.
To ensure technical standardisation and support clinical adoption, comprehensive protocols and standard operating procedures were finalised, covering patient selection, ICG fluorescence administration, intra-operative video capture, and the use of CLASSICA software systems. These support safe and consistent implementation across sites. A robust data management framework has been established, with safeguards at all stages to ensure compliance with GDPR and MDR requirements, including trial monitoring and quality checks at trial sites.
Training has been a key focus, with instructional materials and site-specific onboarding ensuring that clinical users are prepared to use the CLASSICA system in the OR. Resources include educational videos and professional masterclasses for surgeons and OR staff. These videos demonstrate the standardised clinical method for capturing surgical footage and best use of the CLASSICA software.
The groundwork for enhancing clinical guidelines, particularly for TEM procedures, has been laid. This includes the formation of the EAES Task Force and conducting legal, ethical and regulatory framework studies to shape guidelines that are practically applicable and widely accepted.
