High-Grade Glioma (WHO III-IV)IMED-MYVEONCT07164053
Evaluation of Image Quality and Safety of the MyVeo Surgical Visualization Headset During Standard Neurosurgical and Reconstructive Procedures Using Compatible Microscopes.
An observational study of High-Grade Glioma (WHO III-IV) and Cerebral Vascular Conditions Requiring Surgical Intervention, run by Leica Microsystems (Schweiz) AG.
Trial summary
This study looks at how well the MyVeo surgical visualization headset works during routine surgeries. MyVeo is a wearable device that helps surgeons see the surgical area in high detail, including blood flow and tissue fluorescence, without needing to look through a traditional microscope. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High-Grade Glioma (WHO III-IV), Cerebral Vascular Conditions Requiring Surgical Intervention, Conditions Requiring Plastic and Reconstructive Surgery
- What is being tested?
- MyVeo is an all-in-one surgical visualization headset used with compatible surgical microscopes and other medical imaging systems in the area of neurosurgery, ENT, spine, plastic and reconstructive su
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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: The intended target population are patients undergoing a surgical procedure as defined within the intended purpose/indication for use of the respective compatible imaging system.
Who may be able to join
- Candidates for the IMED-MyVeo study protocol must be appropriate patients for the applicable indication of use and have to fulfil 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.
- 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.
- Diagnosed with condition requiring surgical intervention per user manual.
- GLOW400 Specific Inclusion Criteria
- Participants must have a suspected high-grade glioma (WHO grade III-IV) as evidenced by preoperative imaging modalities, which requires surgical intervention.
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- The active substance 5-aminolevulinic acid (5-ALA) fluorescence dye is administered according to the 5-ALA instructions for use.
- GLOW800 Specific Inclusion Criteria
- 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.
- Candidates who meet any of the following exclusion criteria will not be eligible for recruitment in the study.
Who cannot join
- Any uncontrolled systemic condition that may adversely affect the surgical outcome.
- Individuals holding United States citizenship.
- GLOW400 Specific Exclusion Criteria
- Known allergy to 5-ALA hydrochloride or protoporphyrin's.
- Patients with porphyria (a condition characterized by the inability to break down protoporphyrin).
- GLOW800 Specific Exclusion Criteria
- Known allergy to Indocyanine Green (ICG) cyanine dye.
- 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.
About this study
Official title: Image Quality Evaluation of Surgical Visualization Headset (Leica MyVeo) During Standard of Care Procedure Per User Manual
This study looks at how well the MyVeo surgical visualization headset works during routine surgeries. MyVeo is a wearable device that helps surgeons see the surgical area in high detail, including blood flow and tissue fluorescence, without needing to look through a traditional microscope. The study will involve patients undergoing brain, spine, ENT, or reconstructive surgery, where MyVeo is used as part of the standard care. Surgeons will rate the image quality, comfort, and safety of using MyVeo. The goal is to confirm that MyVeo provides clear images and supports safe and effective surgery. No extra procedures or risks are added for patients.
- Conditions
- High-Grade Glioma (WHO III-IV), Cerebral Vascular Conditions Requiring Surgical Intervention, Conditions Requiring Plastic and Reconstructive Surgery
- Being tested
- MyVeo is an all-in-one surgical visualization headset used with compatible surgical microscopes and other medical imaging systems in the area of neurosurgery, ENT, spine, plastic and reconstructive su
- Keywords
- Surgical Visualization Headset, MyVeo, ARveo8x Microscope, Image Quality Assessment, Fluorescence Imaging, White Light Imaging, Neurosurgery, High-Grade Glioma, WHO Grade III-IV Glioma, Indocyanine Green (ICG), 5-Aminolevulinic Acid (5-ALA), GLOW400, GLOW800, Post-Market Clinical Follow-Up (PMCF), Head-Mounted Display (HMD), Stereoscopic 3D Imaging, Surgical Ergonomics, Surgical Workflow, Intraoperative Visualization, Digital Surgical Accessory
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyVeo is an all-in-one surgical visualization headset used with compatible surgical microscopes and other medical imaging systems in the area of neurosurgery, ENT, spine, plastic and reconstructive suDevice
MyVeo is an all-in-one surgical visualization headset used with compatible surgical microscopes (ARveo 8/ARveo 8x) and other medical imaging systems. It is a digital accessory to an operating surgical microscope that enables the visualization of the surgical field through a visualization headset including:
- Display of surgical field illuminated and magnified by the surgical microscope (White Light).
- Display of fluorescence of fluorophores within the indicated excitation and emission ranges, as defined by the respective filters (accessories to the compatible surgical microscopes ARveo 8x such as GLOW400 and GLOW800).
What is being measured
The primary outcome is the main question the study is designed to answer.
White Light and Fluorescence image quality
Image quality will be assessed during surgery using a structured questionnaire completed by the operating surgeon. The evaluation includes white light and fluorescence imaging (GLOW400 and GLOW800) in both main surgeon (3D) and assistant (2D) modes. The following parameters will be rated:
Contrast Color fidelity Stereoscopic/3D impression (main surgeon mode only) Resolution Latency (main surgeon mode only)
Measurement Tool:
MyVeo PMCF Study Data Collection Form - Questionnaire A and B
Scale Range:
5-point Likert scale:
- = Not available
- = Insufficient
- = Sufficient
- = Very good
- = Excellent
Interpretation of Scores:
Scores of 3 or higher are considered acceptable. Ratings below 3 indicate performance concerns. The outcome will be analyzed using binary coding (Pass = 3-5; Fail = 1-2).
Measured: Periprocedural
Secondary outcomes (1)
The secondary objective will be assessed by evaluating the continued safety of the device by monitoring and analyzing adverse events, device-related complications.
Safety and User Experience will be evaluated using Questionnaire, completed postoperatively by the surgical team.
It captures:
Dizziness due to 3D visualization Surgical delays or interruptions Injuries to patient or user Breach of sterility Tissue burns
Responses are binary for Safety:
- = 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.
User Experience
It captures:
- ergonomics and comfort
- adjustability
- workflow
- confidence in terms of decision -making
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 bett
Measured: Postprocedural
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 startOct 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Why it stopped: sufficient existing clinical evidence
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-Grade Glioma (WHO III-IV)Studies 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
- 0 participants (actual)
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
- NCT07164053
- Sponsor's protocol ID
- MYVEO-PMCFSTUDYPLAN-202501
- Acronym
- IMED-MYVEO
- Status last verified
- Oct 2026
- First submitted
- 21 Aug 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image Quality Evaluation of Surgical Visualization Headset (Leica MyVeo) During Standard of Care Procedure Per User Manual
- ClinicalTrials.gov ID
- NCT07164053
- Acronym / sponsor ID
- IMED-MYVEO / MYVEO-PMCFSTUDYPLAN-202501
- Conditions
- High-Grade Glioma (WHO III-IV), Cerebral Vascular Conditions Requiring Surgical Intervention, Conditions Requiring Plastic and Reconstructive Surgery
- Keywords
- Surgical Visualization Headset, MyVeo, ARveo8x Microscope, Image Quality Assessment, Fluorescence Imaging, White Light Imaging, Neurosurgery, High-Grade Glioma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: sufficient existing clinical evidence
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Leica Microsystems (Schweiz) AGIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (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 study looks at how well the MyVeo surgical visualization headset works during routine surgeries. MyVeo is a wearable device that helps surgeons see the surgical area in high detail, including blood flow and tissue fluorescence, without needing to look through a traditional microscope. The study will involve patients undergoing brain, spine, ENT, or reconstructive surgery, where MyVeo is used as part of the standard care. Surgeons will rate the image quality, comfort, and safety of using MyVeo. The goal is to confirm that MyVeo provides clear images and supports safe and effective surgery. No extra procedures or risks are added for patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The intended target population are patients undergoing a surgical procedure as defined within the intended purpose/indication for use of the respective compatible imaging system.
Key inclusion criteria (11 listed)
- Candidates for the IMED-MyVeo study protocol must be appropriate patients for the applicable indication of use and have to fulfil 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.
- 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.
- Diagnosed with condition requiring surgical intervention per user manual.
- GLOW400 Specific Inclusion Criteria
Key exclusion criteria (8 listed)
- Any uncontrolled systemic condition that may adversely affect the surgical outcome.
- Individuals holding United States citizenship.
- GLOW400 Specific Exclusion Criteria
- Known allergy to 5-ALA hydrochloride or protoporphyrin's.
- Patients with porphyria (a condition characterized by the inability to break down protoporphyrin).
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 |
|---|---|---|
| MyVeo is an all-in-one surgical visualization headset used with compatible surgical microscopes and other medical imaging systems in the area of neurosurgery, ENT, spine, plastic and reconstructive suMyVeo is an all-in-one surgical visualization headset used with compatible surgical microscopes (ARveo 8/ARveo 8x) and other medical imaging systems. It is a digital accessory to an operating surgical microscope that enables the visualization of the surgical field through a visualization headset including: * Display of surgical field illuminated and magnified by the surgical microscope (White Light). * Display of fluorescence of fluorophores within the indicated excitation and emission ranges, as defined by the respective filters (accessories to the compatible surgical microscopes ARveo 8x such as GLOW400 and GLOW800). | Device | – |
Primary outcome
White Light and Fluorescence image quality
Time frame: Periprocedural
Image quality will be assessed during surgery using a structured questionnaire completed by the operating surgeon. The evaluation includes white light and fluorescence imaging (GLOW400 and GLOW800) in both main surgeon (3D) and assistant (2D) modes. The following parameters will be rated: Contrast Color fidelity Stereoscopic/3D impression (main surgeon mode only) Resolution Latency (main surgeon mode only) Measurement Tool: MyVeo PMCF Study Data Collection Form - Questionnaire A and B Scale Range: 5-point Likert scale: 1. = Not available 2. = Insufficient 3. = Sufficient 4. = Very good 5. = Excellent Interpretation of Scores: Scores of 3 or higher are considered acceptable. Ratings below 3 indicate performance concerns. The outcome will be analyzed using binary coding (Pass = 3-5; Fail = 1-2).
1 secondary outcome
The secondary objective will be assessed by evaluating the continued safety of the device by monitoring and analyzing adverse events, device-related complications.
Time frame: Postprocedural
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of High-Grade Glioma (WHO III-IV) and Cerebral Vascular Conditions Requiring Surgical Intervention, run by Leica Microsystems (Schweiz) AG.
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 11 inclusion and 8 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: withdrawn, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
White Light and Fluorescence image quality (time frame: Periprocedural). 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 3 Nov 2026.