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Evaluation of Image Quality and Safety of the MyVeo Surgical Visualization Headset During Standard Neurosurgical and Reconstructive Procedures Using Compatible Microscopes.

NCT07164053 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 32

Last updated 2025-11-20

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Leica Microsystems (Schweiz) AG

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-25
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • Spain
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07164053 on ClinicalTrials.gov