This post-market clinical follow-up (PMCF) study aims to confirm the safety and performance of the GLOW800 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 the cerebral vascular area and plastic and reconstructive surgery. 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 a condition requiring surgical intervention in the cerebral vascular area as well as during plastic and reconstructive surgery.
The Indocyanine Green (ICG) cyanine dye is administered as a contrast agent per 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 Indocyanine Green (ICG) cyanine dye.
Any uncontrolled systemic condition that may adversely affect the surgical outcome.
Patients holding United States citizenship.
Severe iodine-induced reactions to macromolecular iodine-containing compounds (e.g., iodinated contrast media, iodine-based antiseptics, or drugs like amiodarone), especially if the reaction involved anaphylaxis or respiratory compromise.
Patient population will include patients diagnosed with condition requiring surgical interventions in the cerebral vascular region as well as during plastic and reconstructive surgery and the patient needs to meet inclusion criteria.
Cohort
Prospective
The GLOW800, a non-contact, non-invasive device, allows the surgical microscope ARveo 8 and ARveo 8X to produce excitation light and resolve fluorescence emission from the fluorescent agent ICG
DeviceWhen activating the GLOW800 mode, the white light illumination of the Leica microscope stand is extended to InfraRed (IR), to excite the fluorophore (ICG). The technology provides ergonomic advantages as the user can maintain an upright posture while observing the surgical field. To excite the fluorophore, ICG dye is illuminated with light at its excitation wavelength band around 750 - 800nm. GLOW800 utilizes a 400w xenon illumination light source integrated as a standard component within the compatible Surgical Operating Microscope (SOM) stand. Activation of the GLOW800 mode extends the white light illumination of the SOM to the infrared (IR) spectral range using a suitable filter placed in the compatible SOM's standard filter wheel for the excitation of the ICG. Each patient enrolled in this study will undergo standard of care for the surgical procedure. No deviations to the standard of care will occur in the execution of this study.
Fluorescence 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 fluorescence visibility in monochrome view 2. Perceived fluorescence visibility in pseudo color view 3. Anatomical and fluorescence observation 4. Fluorescence information given by Indocyanine Green (ICG) 5. Fluorescence information about vessel architecture 6. Fluorescence information about blood flow 7. Fluorescence information about capillary transition 8. Fluorescence information about drainage over venous blood vessels 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. 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).
Anatomical background
Performance will be evaluated using Questionnaire A, a structured Likert-scale survey completed by the operating surgeon during and after surgery. The questionnaire assesses: The visibility of anatomical structures are rated. 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.)
Visibility of real time vascular blood flow
Performance will be evaluated using Questionnaire A, a structured Likert-scale survey completed by the operating surgeon during and after surgery. The questionnaire assesses: Visibility of real-time vascular blood flow 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. 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.
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