The Diagnostic Accuracy of the Device Under Development MULTISCOPE

Conventional gastrointestinal endoscopy relies on ex vivo histopathology, a process limited by diagnostic delays and high costs. The MULTISCOPE project introduces a miniaturized (2.2 mm) endoscopic device integrating advanced optical biopsy with Cold Argon Plasma (CAP) therapy. Utilizing multimodal optical fibers, the system performs label-free, high-resolution imaging via two-photon autofluorescence and second-harmonic generation. Simultaneously, the integrated CAP technology enables targeted oncological treatment by inducing apoptosis and cell-cycle arrest with minimal collateral damage. Given that Endoscopic Submucosal Dissection (ESD) inherently provides samples containing both neoplastic and healthy margins (5-8 mm safety zone), this platform allows for precise, real-time tissue characterization. This in vitro pilot study evaluates the system's diagnostic accuracy in discriminating between healthy and neoplastic colorectal tissues.

Inclusion Criteria: * Colonic or rectal neoplastic lesions resectable by endoscopic submucosal dissection (ESD) * Age ≥ 18 years, male and female * patients with American Society of Anesthesiologists (ASA) grades 1-3 * Signed informed consent Exclusion Criteria: * Severe medical comorbidities precluding endoscopy; * Uncontrolled coagulopathy; * Pregnancy or planned pregnancy during the period of study participation; * Life expectancy ≤2 years, as judged by the site investigator; * Refusal to sign the informed consent.