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

NCT07164053 | Not Yet Recruiting

• 1 other identifier: MYVEO-PMCFSTUDYPLAN-202501
• Study Type: observational
• Target: 32
• Locations: 2 countries
• Sites: 2

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.

Conditions

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

Keywords

Surgical Visualization Headset; MyVeo; ARveo8x Microscope; Image Quality Assessment; Fluorescence Imaging; White Light Imaging; Neurosurgery; High-Grade Glioma; WHO Grade III-IV Glioma; Indocyanine Green (ICG); 5-Aminolevulinic Acid (5-ALA); GLOW400; GLOW800; Post-Market Clinical Follow-Up (PMCF); Head-Mounted Display (HMD); Stereoscopic 3D Imaging; Surgical Ergonomics; Surgical Workflow; Intraoperative Visualization; Digital Surgical Accessory

Outcome Measures

Primary Outcomes (1)

• White Light and Fluorescence image quality

  Image quality will be assessed during surgery using a structured questionnaire completed by the operating surgeon. The evaluation includes white light and fluorescence imaging (GLOW400 and GLOW800) in both main surgeon (3D) and assistant (2D) modes. The following parameters will be rated: Contrast Color fidelity Stereoscopic/3D impression (main surgeon mode only) Resolution Latency (main surgeon mode only) Measurement Tool: MyVeo PMCF Study Data Collection Form - Questionnaire A and B Scale Range: 5-point Likert scale: 1. = Not available 2. = Insufficient 3. = Sufficient 4. = Very good 5. = Excellent Interpretation of Scores: Scores of 3 or higher are considered acceptable. Ratings below 3 indicate performance concerns. The outcome will be analyzed using binary coding (Pass = 3-5; Fail = 1-2).

  Periprocedural

Secondary Outcomes (1)

• The secondary objective will be assessed by evaluating the continued safety of the device by monitoring and analyzing adverse events, device-related complications.

  Postprocedural

Interventions

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 DEVICE

MyVeo is an all-in-one surgical visualization headset used with compatible surgical microscopes (ARveo 8/ARveo 8x) and other medical imaging systems. It is a digital accessory to an operating surgical microscope that enables the visualization of the surgical field through a visualization headset including: * Display of surgical field illuminated and magnified by the surgical microscope (White Light). * Display of fluorescence of fluorophores within the indicated excitation and emission ranges, as defined by the respective filters (accessories to the compatible surgical microscopes ARveo 8x such as GLOW400 and GLOW800).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Leica Microsystems (Schweiz) AG: lead

Study Sites (2)

Hospital Germans Trias I Pujol

Barcelona, Spain

Location

University Hospital Basel

Basel, Switzerland

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Daniela Leal

CONTACT

+41793741989; clinical.affairs@leica-microsystems.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: September 9, 2025
• Study Start: December 25, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CH (1); ES (1)