Status:
NOT_YET_RECRUITING
Evaluation of Image Quality and Safety of the MyVeo Surgical Visualization Headset During Standard Neurosurgical and Reconstructive Procedures Using Compatible Microscopes.
Lead Sponsor:
Leica Microsystems (Schweiz) AG
Conditions:
High-Grade Glioma (WHO III-IV)
Cerebral Vascular Conditions Requiring Surgical Intervention
Eligibility:
All Genders
18+ years
Brief 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 blo...
Eligibility Criteria
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.
- The active substance 5-aminolevulinic acid (5-ALA) fluorescence dye is administered according to the 5-ALA instructions for use.
- GLOW800 Specific Inclusion Criteria
- 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.
- Candidates who meet any of the following exclusion criteria will not be eligible for recruitment in the study.
Exclusion
- 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).
- GLOW800 Specific Exclusion Criteria
- 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.
Key Trial Info
Start Date :
December 25 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT07164053
Start Date
December 25 2025
End Date
June 30 2027
Last Update
November 20 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Germans Trias I Pujol
Barcelona, Spain
2
University Hospital Basel
Basel, Switzerland