Evaluation of Image Quality and Safety of the MyVeo Surgical Visualization Headset During Standard Neurosurgical and Reconstructive Procedures Using Compatible Microscopes. (IMED-MYVEO)

Leica Microsystems (Schweiz) AG

Status: Not yet enrolling

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

Treatments: Device: 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

Study type: Observational

Funder types: Industry

Identifiers

NCT07164053

MYVEO-PMCFSTUDYPLAN-202501

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.