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.
NCT ID: NCT07164040
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
29 participants
OBSERVATIONAL
2026-01-20
2027-07-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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GLOW800
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Leica Microsystems (Schweiz) AG
INDUSTRY
Responsible Party
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Locations
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Unidade Local de Saúde de São João
Porto, , Portugal
Hospital Germans Trias I Pujol
Barcelona, , Spain
University Hospital Basel
Basel, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GLOW800-PMCFSTUDYPLAN-202501
Identifier Type: -
Identifier Source: org_study_id
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