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
Suspected Grade III and IV Gliomas Requiring Surgical InterventionNeurosurgical ProcedureGliomaGlioblastoma (GBM)
Investigational drug(s) / intervention(s)
GLOW400 is a digital surgical microscope accessory used in fluorescent visualization of suspected grade III or IV gliomas during neurosurgery.
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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Inclusion Criteria
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.
Primary outcome measure(s)
Flourescence visibility — Periprocedural Performance will be evaluated using Questionnaire, a structured Likert-scale survey completed by the operating surgeon during and after surgery.
The questionnaire assesses:
1. perceived intensity of fluorescence
2. perceived volume/ shape and relative location
3. perceived distribution of fluorescence
4. anatomical and fluorescence observation (GLOW400 Anatomy only)
Each item is rated on a 5-point Likert scale:
1. = Not available
2. = Insufficient
3. = Sufficient
4. = Very good
5. = Excellent
Higher scores indicate better performance.
The outcome is considered acceptable if all ratings are ≥3 (Sufficient or better).
Image quality — Periprocedural Performance will be evaluated using Questionnaire, a structured Likert-scale survey completed by the operating surgeon during and after surgery. The questionnaire assesses::
1. Stereoscopic Perception (3D Depth perception)
2. Resolution
3. Noise
4. Latency
Each item is rated on a 5-point Likert scale:
1. = Not available
2. = Insufficient
3. = Sufficient
4. = Very good
5. = Excellent
Higher scores indicate better performance.
The outcome is considered acceptable if all ratings are ≥3 (Sufficient or better).
Anatomy of the brain, including Vessels (GLOW400 Anatomy only) — Periprocedural Performance will be evaluated using Questionnaire, a structured Likert-scale survey completed by the operating surgeon during and after surgery. The questionnaire assesses:
1. Neuroanatomy structures
2. Vascular structures 4. Perceived contrast (GLOW400 HiFluo only) 5. Bleeding visibility (GLOW400 Anatomy only) 6. Traces of remaining fluorescence (GLOW400 HiFluo only)
Each item is rated on a 5-point Likert scale:
1. = Not available
2. = Insufficient
3. = Sufficient
4. = Very good
5. = Excellent
Higher scores indicate better performance.
The outcome is considered acceptable if all ratings are ≥3 (Sufficient or better).
Trial sites (2)
Facility
City
Region
Status
Unidade Local de Saúde de São João
Porto
Portugal
University Hospital Basel
Basel
Switzerland
More Leica Microsystems (Schweiz) AG trials in Switzerland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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