Leica Microsystems Sponsored Study to Collect and Confirm Clinical Data on the Performance of the GLOW800 Device When Used in Accordance With Its Intended Use.
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
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: When 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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
Candidates for the study must be appropriate patients for surgical interventions in the cerebral vascular area or for plastic and reconstructive surgery and have to fulfil all of the following inclusion criteria to be eligible for the recruitment of the study.
1. Participants must be 18 years of age or older at the time of signing the informed consent.
2. Participants must have a condition requiring surgical intervention in the cerebral vascular area as well as during plastic and reconstructive surgery.
3. The Indocyanine Green (ICG) cyanine dye is administered as a contrast agent per 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
Exclusion Criteria:
Candidates who meet any of the following exclusion criteria will not be eligible for recruitment in the study.
1. Known allergy to Indocyanine Green (ICG) cyanine dye.
2. Any uncontrolled systemic condition that may adversely affect the surgical outcome.
3. Patients holding United States citizenship.
4. 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.
Primary outcome measure(s)
Fluorescence 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 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 — 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. 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 — Periprocedural 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 — Periprocedural 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).
Trial sites (3)
Facility
City
Region
Status
Unidade Local de Saúde de São João
Porto
Portugal
Recruiting
Hospital Germans Trias I Pujol
Barcelona
Spain
Not Yet Recruiting
University Hospital Basel
Basel
Switzerland
Not Yet Recruiting
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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