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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endoscopic submucosal dissection (ESD)

Procedure

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.

Primary outcomes

Diagnostic Accuracy (Area Under the ROC Curve [AUC]) of the MULTISCOPE Device for Differentiating Normal versus Neoplastic Colorectal Tissue

Time frame: At the time of histopathological evaluation, approximately 2 weeks after the surgical procedure.

The diagnostic accuracy of optical biopsies performed with the two-photon microendoscope MULTISCOPE prototype will be assessed and compared against standard ex vivo histopathology (gold standard) as the reference diagnosis.

Diagnostic performance will be evaluated based on the Area Under the Receiver Operating Characteristic Curve (AUC). Optimal sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) with 95% confidence intervals will also be calculated using the Youden Index threshold. AUC values range from 0.5 (no discrimination) to 1.0 (perfect diagnostic accuracy).

Secondary outcomes

Tumor Cell Destruction Rate After Cold Atmospheric Plasma (CAP) Exposure

Time frame: Up to 12 months (at the end of the study).

The therapeutic efficacy of MULTISCOPE expressed as the proportion of treated/affected cells after CAP exposure, quantified in commercial gastrointestinal tumor organoids.

Study contacts

Contact information is provided by the study sponsor or research team.

IVO BOSKOSKI

CONTACT

[email protected]

+39 06 3015 6580

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

In Vitro Pilot Study to Assess the Diagnostic Accuracy of the Device Under Development MULTISCOPE

Acronym: MULTISCOPE

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Sep 17, 2026
Registry last updated: Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not yet recruiting