Surgeons test High-Tech headset for better views in the operating room
NCT ID NCT07164053
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests how well the MyVeo surgical headset shows surgical details during routine brain, spine, ear-nose-throat, or reconstructive surgeries. Surgeons will rate image quality, comfort, and safety while using the device. About 32 patients will take part, and no extra procedures or risks are added beyond standard care.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The intended target population are patients undergoing a surgical procedure as defined within the intended purpose/indication for use of the respective compatible imaging system.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. Exclusion Criteria: 1. Any uncontrolled systemic condition that may adversely affect the surgical outcome. 2. Individuals holding United States citizenship. GLOW400 Specific Exclusion Criteria 3. Known allergy to 5-ALA hydrochloride or protoporphyrin's. 4. Patients with porphyria (a condition characterized by the inability to break down protoporphyrin). GLOW800 Specific Exclusion Criteria 5. Known allergy to Indocyanine Green (ICG) cyanine dye. 6. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital Germans Trias I Pujol
Barcelona, Spain
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University Hospital Basel
Basel, Switzerland
More trials for these conditions
Other studies related to the condition(s) this trial covers.