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NCT07366892Not yet recruiting

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

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.

Inclusion 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. 1. Participants must be 18 years of age or older at the time of signing the informed consent. 2. Participants must have suspected high-grade glioma (WHO grade III-IV) as evidenced by preoperative imaging modalities, which require surgical intervention. 3. The active substance 5-aminolevulinic acid (5-ALA) fluorescence dye is administered according to the 5-ALA instructions for use. 4. 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.

Exclusion criteria

1. Known allergy to 5-ALA hydrochloride or protoporphyrin. 2. Patients with porphyria (a condition characterized by the inability to break down protoporphyrin). 3. Any uncontrolled systemic condition that may adversely affect the surgical outcome. 4. Patients holding United States citizenship.

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Not yet recruiting
Phase
—
Study type
Observational
Countries
Switzerland, Portugal
Sponsor
Leica Microsystems (Schweiz) AG(Industry)
Protocol no.
GLOW400-PMCFSTUDYPLAN-202501
Conditions
Suspected Grade III and IV Gliomas Requiring Surgical Intervention, Neurosurgical Procedure, Glioma, Glioblastoma (GBM)
Interventions
Device

Treatments studied

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

Locations · 2

  • Basel, SwitzerlandUniversity Hospital BaselNot yet recruiting at this site
  • Porto, PortugalUnidade Local de Saúde de São JoãoNot yet recruiting at this site

In total, worldwide, both sites listed in the registry are planned; recruitment has not opened yet.

Site status per the ClinicalTrials.gov registry (last update posted: January 26, 2026).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.