Clinical trial · Interventional
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
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| endoscopic submucosal dissection (ESD) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients who require endoscopy with endoscopic submucosal dissection (ESD) of the colon.
- description
- Thirty consecutive colorectal specimens resected via endoscopic submucosal dissection (ESD) will be analyzed. Each specimen serves as an internal control, comprising both central neoplasia and healthy peripheral margins ("fried-egg" morphology). To ensure maximum accuracy with this novel device, optical biopsies will be performed on both tissue types immediately prior to formal histopathological fixation. ESD procedures will be conducted at the Agostino Gemelli Foundation, while optical and histopathological analyses will be centralized at the Catholic University of Rome (UCSC).
- interventionNames
- Procedure: endoscopic submucosal dissection (ESD)
Primary outcomes (1)
- measure
- Diagnostic Accuracy (Area Under the ROC Curve [AUC]) of the MULTISCOPE Device for Differentiating Normal versus Neoplastic Colorectal Tissue
- timeFrame
- At the time of histopathological evaluation, approximately 2 weeks after the surgical procedure.
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available