Набор скоро начнётся NCT07164053

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

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

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: 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.
Кому может быть актуально: Состояния в реестре: High-Grade Glioma (WHO III-IV), Cerebral Vascular Conditions Requiring Surgical Intervention, Conditions Requiring Plastic and Reconstructive Surgery. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Испания, Швейцария
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

Устройство 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
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,

Первичные конечные точки

White Light and Fluorescence image quality [Срок оценки: Periprocedural]

Вторичные конечные точки (1)

The secondary objective will be assessed by evaluating the continued safety of the device by monitoring and analyzing adverse events, device-related complications. [Срок оценки: Postprocedural]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет