Reconstructive Surgical ProceduresIMED-GLOW800NCT07164040
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.
An observational study of Reconstructive Surgical Procedures and Plastic Surgery, run by Leica Microsystems (Schweiz) AG at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reconstructive Surgical Procedures, Plastic Surgery, Vascular Surgical Procedure
- What is being tested?
- 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
- Type of treatment
- Medical device
- How many people
- 29 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 20 Jan 2026to 30 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Portugal1 site, 1 recruiting
- Recruiting
Unidade Local de Saúde de São João
Porto
Pedro Alberto Silva, MD PhD FEBNS, +351 933 205 202, pa.silva@ulssjoao.min-saude.pt
Spain1 site, 1 recruiting
- Not yet recruiting
Hospital Germans Trias I Pujol
Barcelona
Carmen Higueras Sune, MD PhD, +34935240896, chigueras.germanstrias@gencat.cat
Switzerland1 site, 1 recruiting
- Not yet recruiting
University Hospital Basel
Basel
Raphael Guzman, Prof. med., +41 61 265 33 68, raphael.guzman@usb.ch
About this study
Official 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)
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.
Read the 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.
- Conditions
- Reconstructive Surgical Procedures, Plastic Surgery, Vascular Surgical Procedure, Cerebrovascular Disorder
- Being tested
- 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
- 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
- Medical subject headings
- Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 ICGDevice
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 group | Role | What they receive |
|---|---|---|
| GLOW800 | Not described Receives: Device: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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).
Measured: Periprocedural
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:
- 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).
Measured: Periprocedural
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:
- = 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.)
Measured: Periprocedural
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:
- = 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).
Measured: Periprocedural
Secondary outcomes (1)
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:
- 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.
Measured: Postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start20 Jan 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reconstructive Surgical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leica Microsystems (Schweiz) AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164040
- Sponsor's protocol ID
- GLOW800-PMCFSTUDYPLAN-202501
- Acronym
- IMED-GLOW800
- Status last verified
- Jan 2026
- First submitted
- 15 Aug 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD used in the results publication.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07164040
- Acronym / sponsor ID
- IMED-GLOW800 / GLOW800-PMCFSTUDYPLAN-202501
- Conditions
- Reconstructive Surgical Procedures, Plastic Surgery, Vascular Surgical Procedure, Cerebrovascular Disorder
- Keywords
- GLOW800, Indocyanine-green (ICG), Near Infrared, plastic and reconstructive surgery, ARveo8X, Surgical Microscope, Fluorescence imaging, Cerebrovascular surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Leica Microsystems (Schweiz) AGIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GLOW800 | – | Device: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 ICGWhen 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. | Device | GLOW800 |
Primary outcome
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: 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
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: 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
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: 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
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: 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).
1 secondary outcome
The secondary objectives of this Post-Market Clinical Follow-up (PMCF) study are to assess the continued safety of the device.
Time frame: Postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: Yes. IPD used in the results publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reconstructive Surgical Procedures and Plastic Surgery, run by Leica Microsystems (Schweiz) AG at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Portugal, Spain, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniela Leal (+41793741989, clinical.affairs@leica-microsystems.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluorescence visibility. (time frame: Periprocedural). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.