NCT07164053
Evaluation of Image Quality and Safety of the MyVeo Surgical Visualization Headset During Standard Neurosurgical and Reconstructive Procedures Using Compatible Microscopes.
Not Yet Recruiting · Not specified · Leica Microsystems (Schweiz) AG · registry updated 2025-11-20
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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.
Exclusion
- exclusion criteria will not be eligible for recruitment in the study.
- 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).