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
Starting soon
Conditions studied: Suspected Grade III and IV Gliomas Requiring Surgical Intervention, Neurosurgical Procedure, Glioma, Glioblastoma (GBM)
In brief
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.
Key facts
- Study ID
- NCT07366892
- Run by
- Leica Microsystems (Schweiz) AG
- People needed
- 37
- Starts
- 2026-02-01
- Expected to finish
- 2027-05-31
- Last updated by the study team
- 2026-01-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Unidade Local de Saúde de São João — Porto, Portugal
- University Hospital Basel — Basel, Switzerland
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.