Clinical trial · Interventional
CONVIVO Endomicroscopy
A Feasibility Analysis of an in Vivo CONVIVO Endomicroscopy During Brain Surgery.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Visualization of the tissue microstructure during neurosurgery using a non destructive handheld imaging technology producing a real time digital image ("optical biopsy") at cellular resolution is a novel method that holds great promise for optimization and improvement of the surgical treatment of brain pathologies, brain tumors in particular. The goal of this project is to investigate and assess the ease of use of the CONVIVO FDA cleared system in discriminating healthy and abnormal tissues during in vivo use on the brain during neurosurgery in 30 patients with a working diagnosis of intrinsic brain tumors.
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 |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CONVIVO | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Investigate ease of CONVIVO.
- timeFrame
- one year
- description
- The outcome is to investigate and assess the ease of use of the CONVIVO FDA cleared system in discriminating healthy and abnormal tissues during in vivo use on the brain during neurosurgery in 30 patients with a working diagnosis of intrinsic brain tumors.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * . The patient is suffering from an intracranial lesion requiring surgery: * Patients undergoing neurosurgical resection for intrinsic presumably high grade, invasive tumors. * Patients undergoing neurosurgical resection for other brain tumors,. * All patient groups will only be comprised of elective surgical patients who have signed the informed consent prior to use Exclusion Criteria: * History of hypersensitivity to fluorescein * History of allergy or bronchial asthma * Renal failure - Children (patients less than 18 years of age) * Pregnant women * Breast feeding women * Patients with inability to give informed consent
References
Publications (1)
- BACKGROUNDAcerbi, F., Pollo, B., De Laurentis, C., Restelli, F., Falco, J., Vetrano, I. G., ... & DiMeco, F. (2020). Ex Vivo Fluorescein-Assisted Confocal Laser Endomicroscopy (CONVIVO® System) in Patients With Glioblastoma: Results From a Prospective Study. Frontiers in Oncology, 10. Belykh, E., Miller, E. J., Patel, A. A., Yazdanabadi, M. I., Martirosyan, N. L., Yağmurlu, K., ... & Preul, M. C. (2018). Diagnostic accuracy of a confocal laser endomicroscope for in vivo differentiation between normal injured and tumor tissue during fluorescein-guided glioma resection. World neurosurgery, 115, e337-e348