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Taking people in PortugalNo phase

Observes a device that helps surgeons see suspected brain tumors

Checks a surgical microscope accessory during brain surgery for suspected gliomas in adults.

Key facts

Who runs it
Leica Microsystems (Schweiz) AG
Where
Porto, PortugalSee the siteAlso in 1 other country, 1 site
Trial code
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
Status
Recruiting
People taking part
37 people, planned
Started
28 Apr 2026
Expected to end
31 Aug 2027
Type of study
Observational
Treatments tested
  • GLOW400 is a digital surgical microscope accessory used in fluorescent visualization of suspected grade III or IV gliomas during neurosurgery.
Record updated
3 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a suspected high-grade brain tumour (glioma, WHO grade III-IV) who need surgery and are given the dye 5-ALA.

Age
18 years or older
Sex
All sexes
Disease stage
Suspected high-grade glioma (WHO grade III-IV) seen on scans before surgery, needing surgery
Earlier treatment
The dye 5-aminolevulinic acid (5-ALA) is given as described in its instructions for use

Main reasons for not taking part

  • Known allergy to 5-ALA hydrochloride or protoporphyrin
  • Porphyria
  • Any uncontrolled illness in the body that may harm the surgical outcome
  • United States citizenship
  • In Switzerland, people who cannot give consent themselves

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Other criteria

  • 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

Where in Portugal

Also in 1 other country, 1 site

  • Unidade Local de Saúde de São JoãoPorto, PortugalContact: Pedro Alberto Silva, MD PhD FEBNSTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • GLOW400

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Fluorescence Visualization and Image Quality Evaluation of Digital Visualization of Suspected Grade III and/or IV Gliomas During Neurosurgery (Leica GLOW400)
Plain-language title
Observes a device that helps surgeons see suspected brain tumorsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
3 November 2026