Not Yet RecruitingNot Applicable

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

Portugal, Switzerland37 participantsStarted 2026-02-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Flourescence visibility

Timeframe: Periprocedural

Image quality

Timeframe: Periprocedural

Anatomy of the brain, including Vessels (GLOW400 Anatomy only)

Timeframe: Periprocedural

Trial details

NCT IDNCT07366892

SponsorLeica Microsystems (Schweiz) AG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-12-20

Contact for this trial

Daniela Leal

+41793741989 daniela.leal@leica-microsystems.com

View on ClinicalTrials.gov More Suspected Grade III and IV Gliomas Requiring Surgical Intervention trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.