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ClinicalTrials.gov ID

NCT07164053

Lead Sponsor

Leica Microsystems (Schweiz) AGINDUSTRY

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

32Estimated

Last Update Posted

Nov 20, 2025Actual

Start Date

Dec 25, 2025Estimated

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Jun 30, 2027Estimated

Official Title

Image Quality Evaluation of Surgical Visualization Headset (Leica MyVeo) During Standard of Care Procedure Per User Manual

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 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.

• High-Grade Glioma (WHO III-IV)
• Cerebral Vascular Conditions Requiring Surgical Intervention
• Conditions Requiring Plastic and Reconstructive Surgery

• 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

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Leica Microsystems (Schweiz) AGINDUSTRY

raphael.guzman@usb.ch+41 61 265 33 68