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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

NCT07366892 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 37

Last updated 2026-01-26

No results posted yet for this study

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.

Conditions

  • Suspected Grade III and IV Gliomas Requiring Surgical Intervention
  • Neurosurgical Procedure
  • Glioma
  • Glioblastoma (GBM)

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Leica Microsystems (Schweiz) AG

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2026-12-20
Completion
2027-05-31

Countries

  • Portugal
  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07366892 on ClinicalTrials.gov