Cerebral Vascular Conditions Requiring Surgical Intervention, Conditions Requiring Plastic and Reconstructive Surgery, High-Grade Glioma (WHO III-IV)
Conditions
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
Brief 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. 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.
Interventions
DEVICEMyVeo 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
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).
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 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. 1. Participants must be 18 years of age or older at the time of signing the informed consent. 2. 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. 3. Diagnosed with condition requiring surgical intervention per user manual. GLOW400 Specific Inclusion Criteria 4. Participants must have a suspected high-grade glioma (WHO grade III-IV) as evidenced by preoperative imaging modalities, which requires surgical intervention. 5. The active substance 5-aminolevulinic acid (5-ALA) fluorescence dye is administered according to the 5-ALA instructions for use. GLOW800 Specific Inclusion Criteria 6. Participants must have a condition requiring surgical intervention in the cerebral vascular area as well as during plastic and reconstructive surgery. 7. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| White Light and Fluorescence image quality | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The secondary objective will be assessed by evaluating the continued safety of the device by monitoring and analyzing adverse events, device-related complications. | Postprocedural | 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: 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. User Experience It captures: 1. ergonomics and comfort 2. adjustability 3. workflow 4. confidence in terms of decision -making 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 bett |
Countries
Spain, Switzerland
Contacts
Primary ContactDaniela Leal
Outcome results
None listed