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.
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.
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.
Patient population will include patients with suspected grade III or IV gliomas requiring surgical intervention, and who meet the Inclusion/Exclusion Criteria for the IMED-GLOW400 Study.
Cohort
Prospective
GLOW400 is a digital surgical microscope accessory used in fluorescent visualization of suspected grade III or IV gliomas during neurosurgery.
DeviceThe 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.
Flourescence visibility
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
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)
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).
The secondary objectives of this Post-Market Clinical Follow-up (PMCF) study are to assess the continued safety of the device.
Safety will be evaluated using Questionnaire B, completed postoperatively by the surgical team. It captures: 1. Dizziness through using digital 3D visualization 2. Delayed, interrupted or hindered surgery due to different causes 3. Occurred injuries to the patient 4. Breach of sterility 5. Any patient or user tissue burn event reported. 6. Confirm user experience with the use of the device in real clinical practice, supporting the marketing claims: 1. Confidence in decision 2. Focus during procedure 3. Surgical course of action 4. User experience 5. Mental fatigue Responses are binary: 1. = Yes (event occurred) 2. = No (event did not occur) Lower scores (2 = No) indicate better safety outcomes. The outcome is acceptable if no safety events are reported.
Assessment of the extent of tumor resection
The extent of tumor resection will be evaluated using volumetric analysis. The volumetric measurement will be carried out by a neuroradiologist. Precise three-dimensional (3D) rendering and analysis of pre-operative and post-operative MRI images, facilitating accurate assessment of residual tumor volume. Radiology reports include: • Residual tumor percentage %. Based on the residual tumor percentage, the appropriate category will be selected (4): * Complete tumor resection: (100% + 0 cm3 CE) * Near total resection: (≥ 95% + ≤ 1 cm3 CE) * Subtotal resection: (≥ 80% + ≤ 5 cm3 CE) * Partial resection: (\< 80% ± \>5 cm3 CE)
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