Trials / Not Yet Recruiting
Not Yet RecruitingNCT07164053
Evaluation of Image Quality and Safety of the MyVeo Surgical Visualization Headset During Standard Neurosurgical and Reconstructive Procedures Using Compatible Microscopes.
Image Quality Evaluation of Surgical Visualization Headset (Leica MyVeo) During Standard of Care Procedure Per User Manual
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 32 (estimated)
- Sponsor
- Leica Microsystems (Schweiz) AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- High-Grade Glioma (WHO III-IV)
- Cerebral Vascular Conditions Requiring Surgical Intervention
- Conditions Requiring Plastic and Reconstructive Surgery
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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 | 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). |
Timeline
- Start date
- 2025-12-25
- Primary completion
- 2026-12-31
- Completion
- 2027-06-30
- First posted
- 2025-09-09
- Last updated
- 2025-11-20
Locations
2 sites across 2 countries: Spain, Switzerland
Source: ClinicalTrials.gov record NCT07164053. Inclusion in this directory is not an endorsement.