Cerebrovascular Disorder, Plastic Surgery, Reconstructive Surgical Procedures, Vascular Surgical Procedure
Conditions
Keywords
GLOW800, Indocyanine-green (ICG), Near Infrared, plastic and reconstructive surgery, ARveo8X, Surgical Microscope, Fluorescence imaging, Cerebrovascular surgery, Intraoperative visualization, Post-market clinical follow-up (PMCF), Image quality assessment, 3D visualization, Heads-up surgery, Vascular imaging, Digital surgical workflow
Brief 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.
Detailed description
The IMED-GLOW800 study is designed to collect clinical data on the GLOW800 device, a CE-marked surgical microscope accessory developed by Leica Microsystems. The device enables enhanced intraoperative visualization of blood flow using Indocyanine Green (ICG) fluorescence, integrated into the surgical field in real-time with stereoscopic depth perception. Traditional ICG-guided surgery often requires switching between anatomical and fluorescence views, which can interrupt surgical workflow. GLOW800 overcomes this limitation by digitally overlaying fluorescence signals onto the anatomical view, improving surgical decision-making and workflow efficiency. The study will enroll 31 patients across at least two sites in the European Economic Area (EEA) and Switzerland. Eligible patients will undergo standard surgical procedures in the cerebral vascular area or plastic and reconstructive surgery. The study does not involve additional invasive procedures and is conducted entirely within the scope of routine care. The primary objective is to assess the performance of GLOW800 in terms of fluorescence visibility and image quality. Secondary objectives include evaluating the continued safety of the device. Data will be collected using structured questionnaires completed by surgeons during and after surgery, along with video recordings captured by the microscope. Endpoints include: Primary: Fluorescence visibility (monochrome and pseudo-color), anatomical and fluorescence observations, vessel architecture, blood flow, capillary transition, drainage, stereoscopic perception, resolution, latency, and real-time blood flow visibility. Secondary: Safety indicators such as dizziness, surgical interruptions, injuries, sterility breaches, and tissue burns. The study duration is estimated at 5-6 months from first patient enrollment to completion. Each patient will participate in a single surgical procedure with no follow-up required. Data will be pseudonymized and managed in compliance with GDPR and ISO 14155:2020. The study is sponsored by Leica Microsystems (Schweiz) AG and will be monitored according to standard clinical research practices. The results will contribute to ongoing post-market surveillance and may support regulatory submissions, scientific publications, and future product development.
Interventions
DEVICEThe 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.
Sponsors
Leica Microsystems (Schweiz) AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The secondary objectives of this Post-Market Clinical Follow-up (PMCF) study are to assess the continued safety of the device. | Postoperatively | 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. |
Countries
Portugal, Spain, Switzerland
Contacts
CONTACTDaniela Leal
Outcome results
None listed