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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
Sponsor: Leica Microsystems (Schweiz) AG
Summary
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.
Official title: Fluorescence Visualization and Image Quality Evaluation of Digital Visualization of Suspected Grade III and/or IV Gliomas During Neurosurgery (Leica GLOW400)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
37
Start Date
2026-02-01
Completion Date
2027-05-31
Last Updated
2026-01-26
Healthy Volunteers
No
Conditions
Interventions
GLOW400 is a digital surgical microscope accessory used in fluorescent visualization of suspected grade III or IV gliomas during neurosurgery.
The digital surgical microscope accessory GLOW400 is using the optical excitation and emission filtering of the FL400. The FL400 provides an illumination filter (380nm - 430nm) which when engaged into the light source path of the surgical operating microscope provides, via a light guide, a fluorescence excitation light system used in conjunction with an approved tumor-selective substance (fluorophore) (e.g. Protoporphyrin IX (PpIX) which is resulting of the metabolization of 5-ALA (5 - aminolaevulinic acid)) for tissue characterization in the open neurosurgery field. PpIX is strongly fluorescent with a peak at λ=635 nm as red-violet after excitation with blue light (λ=380-410 nm). The digital surgical microscope accessory GLOW400 is using the optical excitation and emission filtering of the FL400. The fluorescence signal visualized depicts the distribution of the dye in the patient's tissues during the surgical procedure.
Locations (2)
Unidade Local de Saúde de São João
Porto, Portugal
University Hospital Basel
Basel, Switzerland