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The Diagnostic Accuracy of the Device Under Development MULTISCOPE
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Summary
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.
Official title: In Vitro Pilot Study to Assess the Diagnostic Accuracy of the Device Under Development MULTISCOPE
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-11-02
Completion Date
2027-06-30
Last Updated
2026-09-17
Healthy Volunteers
No
Conditions
Interventions
endoscopic submucosal dissection (ESD)
Protocol and Transport Colorectal ESD specimens will be resected at the Fondazione Gemelli IRCCS and immediately transported dry (without formalin) to the UCSC Pathological Anatomy Unit within 15 minutes. To ensure tissue viability, dedicated staff will coordinate the transfer directly from the endoscopy suite. Ex Vivo Analysis The MULTISCOPE device will be stationed at the UCSC facility, adjacent to the pathology lab. Upon arrival, Prof. Vincenzo Arena's team will perform multimodal fiberoptic optical biopsies on both healthy and neoplastic mucosa before proceeding with standard histopathological processing.