Evaluation of Image Quality and Safety of the MyVeo Surgical Visualization Headset During Standar… (NCT07164053) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of Image Quality and Safety of the MyVeo Surgical Visualization Headset During Standard Neurosurgical and Reconstructive Procedures Using Compatible Microscopes.
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Participants must have a suspected high-grade glioma (WHO grade III-IV) as evidenced by preoperative imaging modalities, which requires surgical intervention.
✓. The active substance 5-aminolevulinic acid (5-ALA) fluorescence dye is administered according to the 5-ALA instructions for use.
✓. 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.
. Any uncontrolled systemic condition that may adversely affect the surgical outcome.
✕. Individuals holding United States citizenship.
✕. Known allergy to 5-ALA hydrochloride or protoporphyrin's.
✕. Patients with porphyria (a condition characterized by the inability to break down protoporphyrin).
✕. 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.