This post-market clinical follow-up (PMCF) study aims to confirm the safety and performance of the GLOW400 surgical microscope accessory when used in conjunction with the ARveo8x surgical microscope. The study evaluates fluorescence visualization and image quality during standard surgical procedures in neurosurgery. It is a non-interventional, observational study conducted in routine care settings across multiple European sites.
Participants must be 18 years of age or older at the time of signing the informed consent.
Participants must have suspected high-grade glioma (WHO grade III-IV) as evidenced by preoperative imaging modalities, which require surgical intervention.
The active substance 5-aminolevulinic acid (5-ALA) fluorescence dye is administered according to the 5-ALA instructions for use.
The participant or their legal representative must understand the study and have voluntarily signed and dated the Informed Consent Form, which has been approved by the Sponsor and the Ethics Committee for this study.
Known allergy to 5-ALA hydrochloride or protoporphyrin.
Patients with porphyria (a condition characterized by the inability to break down protoporphyrin).
Any uncontrolled systemic condition that may adversely affect the surgical outcome.
Patients holding United States citizenship.