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NCT Number: NCT07164040

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.

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.

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Key information

Conditions

Reconstructive Surgical Procedures Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorder Cerebrovascular Disorders Nervous System Diseases Plastic Surgery Vascular Diseases Vascular Surgical Procedure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Unidade Local de Saúde de São João, Porto, Portugal

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

  • 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

Exclusion criteria

Candidates who meet any of the following exclusion criteria will not be eligible for recruitment in the 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.

Treatment and study plan

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

Device

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.

Primary outcomes

  1. Fluorescence visibility.

    Time frame: Periprocedural

    Performance will be evaluated using Questionnaire, a structured Likert-scale survey completed by the operating surgeon during and after surgery.

    The questionnaire assesses:

    • Perceived fluorescence visibility in monochrome view
    • Perceived fluorescence visibility in pseudo color view
    • Anatomical and fluorescence observation
    • Fluorescence information given by Indocyanine Green (ICG)
    • Fluorescence information about vessel architecture
    • Fluorescence information about blood flow
    • Fluorescence information about capillary transition
    • Fluorescence information about drainage over venous blood vessels

    Each item is rated on a 5-point Likert scale:

    • = Not available
    • = Insufficient
    • = Sufficient
    • = Very good
    • = Excellent Higher scores indicate better performance. The outcome is considered acceptable if all ratings are ≥3 (Sufficient or better).

  2. Image quality

    Time frame: Periprocedural

    Performance will be evaluated using Questionnaire, a structured Likert-scale survey completed by the operating surgeon during and after surgery. The questionnaire assesses:

    • Stereoscopic Perception (3D Depth perception)
    • Resolution
    • Latency

    Each item is rated on a 5-point Likert scale:

    • = Not available
    • = Insufficient
    • = Sufficient
    • = Very good
    • = Excellent Higher scores indicate better performance. The outcome is considered acceptable if all ratings are ≥3 (Sufficient or better).

  3. Anatomical background

    Time frame: 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:

    • = Not available
    • = Insufficient
    • = Sufficient
    • = Very good
    • = Excellent Higher scores indicate better performance. The outcome is considered acceptable if all ratings are ≥3 (Sufficient or better.)

  4. Visibility of real time vascular blood flow

    Time frame: 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:

    • = Not available
    • = Insufficient
    • = Sufficient
    • = Very good
    • = Excellent Higher scores indicate better performance. The outcome is considered acceptable if all ratings are ≥3 (Sufficient or better).

Secondary outcomes

  1. The secondary objectives of this Post-Market Clinical Follow-up (PMCF) study are to assess the continued safety of the device.

    Time frame: Postoperatively

    Safety will be evaluated using Questionnaire B, completed postoperatively by the surgical team. It captures:

    • Dizziness through using digital 3D visualization
    • Delayed, interrupted or hindered surgery due to different causes
    • Occurred injuries to the patient
    • Breach of sterility
    • Any patient or user tissue burn event reported.

    Responses are binary:

    • = Yes (event occurred)
    • = No (event did not occur) Lower scores (2 = No) indicate better safety outcomes. The outcome is acceptable if no safety events are reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniela Leal

CONTACT

[email protected]

+41793741989

Sponsors and collaborators

Lead sponsor

Leica Microsystems (Schweiz) AG

Industry

Registry information

Official study title

Fluorescence Visualization and Image Quality Evaluation of Digital Visualization During Standard of Care Procedure in the Cerebral Vascular Area as Well as Blood Flow During Plastic and Reconstructive Surgery (PRS) (Leica GLOW800)

Acronym: IMED-GLOW800

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Sep 9, 2025
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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