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RecruitingNot a traditional drug phaseobservationalRules rewrite

Not a traditional drug phase: GLOW400 is a digital surgical microscope accessory used in fluorescent visualization of suspected grade III or IV gliomas during neurosurgery. for Suspected Grade III and IV Gliomas Requiring Surgical Intervention

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.

Official registry: https://clinicaltrials.gov/study/NCT07366892 · Leica Microsystems (Schweiz) AG · enrollment listed as 37

What this phase means

This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.

They plan to enroll about 37 people at 2 sites. Taking part typically means using or being fitted with a device plus check-ins.

Official title (unrewritten)

Fluorescence Visualization and Image Quality Evaluation of Digital Visualization of Suspected Grade III and/or IV Gliomas During Neurosurgery (Leica GLOW400)

Interventions: GLOW400 is a digital surgical microscope accessory used in fluorescent visualization of suspected grade III or IV gliomas during neurosurgery.

Primary outcome (registry wording): Flourescence visibility

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • 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
  • Note for Switzerland only:

Public study contact (from the registry)

Leica Microsystems Clinical Affairs Department

+41 796428004

clinical.affairs@leica-microsystems.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

2 listed

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FAQ about this NCT record

Is NCT07366892 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07366892?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07366892?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary