NCT07366892

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

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 37 (estimated)
• Sponsor: Leica Microsystems (Schweiz) AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The IMED-GLOW400 study is a prospective, observational, non-interventional clinical investigation conducted in the European Economic Area and Switzerland. It involves the use of the GLOW400 accessory, which digitally enhances fluorescence signals during neurosurgery, providing improved anatomical visualization and contrast. The study compares GLOW400 with the benchmark FL400 optical filter system. The primary objective is to confirm the image quality and fluorescence visualization performance of GLOW400. Secondary objectives include validating product claims and assessing user experience and safety. An exploratory objective evaluates the extent of tumor resection using volumetric analysis of pre- and post-operative MRI scans. Data will be collected through structured questionnaires, histopathology confirmation, optional resection forms, and intraoperative video recordings. The study will enroll 37 patients, with at least 29 complete datasets required for analysis. The duration of the study is estimated at 5 to 6 months, with each patient participating only during the surgical procedure. The study complies with ISO 14155:2020, GDPR, and the Declaration of Helsinki. Ethics Committee approval and informed consent are mandatory prior to enrollment. No additional procedures beyond standard of care are introduced, and risks are limited to those associated with routine surgical practice.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-12-20
• Completion: 2027-05-31
• First posted: 2026-01-26
• Last updated: 2026-01-26

Locations

2 sites across 2 countries: Portugal, Switzerland