Observes a device that helps surgeons see suspected brain tumors
Checks a surgical microscope accessory during brain surgery for suspected gliomas in adults.
Plain-language title generated from the registry record
Registry title: Leica Microsystems Sponsored PMCF Study to Collect and Confirm Clinical Data on the Performance of the GLOW400 Device When Used in Accordance With Its Intended Use
Key facts
- Where
- Basel, SwitzerlandSee the site
Where in Switzerland
- University Hospital BaselBasel, SwitzerlandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Leica Microsystems (Schweiz) AG
- Trial code
- NCT07366892
- Record updated
- 3 November 2026
- Original description
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.Read full original descriptionShow less
Fluorescence Visualization and Image Quality Evaluation of Digital Visualization of Suspected Grade III and/or IV Gliomas During Neurosurgery (Leica GLOW400)
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.
Inclusion: 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; Note for Switzerland only:; Enrollment via legal representative is not permitted. Therefore, only patients who are capable of providing informed consent themselves will be eligible for inclusion in Switzerland.
Exclusion: 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.
Candidates for the for the IMED-GLOW400 Study must be appropriate patients for surgical interventions with suspected intracranial high-grade glioma evidenced by preoperative imaging modalities and have to fulfil all of the following inclusion criteria to be eligible for the recruitment of the study.