NCT07826611Not yet recruiting
The Diagnostic Accuracy of the Device Under Development MULTISCOPE
In Vitro Pilot Study to Assess the Diagnostic Accuracy of the Device Under Development MULTISCOPE
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 22 Dec 2025
- Start date
- 2 Nov 2026
- Primary completion date
- 2 Feb 2027
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Colorectal cancer
- NCT number
- NCT07826611
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 2 Nov 2026 to the primary completion date, 2 Feb 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Life expectancy ≤2 years, as judged by the site investigator;
Other
- Severe medical comorbidities precluding endoscopy;
- Uncontrolled coagulopathy;
- Pregnancy or planned pregnancy during the period of study participation;
- Refusal to sign the informed consent.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.