Leica Microsystems Sponsored Study to Collect and Confirm Clinical Data on the Performance of the GLOW800 Device When Used in Accordance With Its Intended Use.

Официальное название

Fluorescence Visualization and Image Quality Evaluation of Digital Visualization During Standard of Care Procedure in the Cerebral Vascular Area as Well as Blood Flow During Plastic and Reconstructive Surgery (PRS) (Leica GLOW800)

Обзор

This post-market clinical follow-up (PMCF) study aims to confirm the safety and performance of the GLOW800 surgical microscope accessory when used in conjunction with the ARveo8x surgical microscope. The study evaluates fluorescence visualization and image quality during standard surgical procedures in the cerebral vascular area and plastic and reconstructive surgery. It is a non-interventional, observational study conducted in routine care settings across multiple European sites.

Подробное описание

The IMED-GLOW800 study is designed to collect clinical data on the GLOW800 device, a CE-marked surgical microscope accessory developed by Leica Microsystems. The device enables enhanced intraoperative visualization of blood flow using Indocyanine Green (ICG) fluorescence, integrated into the surgical field in real-time with stereoscopic depth perception.

Traditional ICG-guided surgery often requires switching between anatomical and fluorescence views, which can interrupt surgical workflow. GLOW800 overcomes this limitation by digitally overlaying fluorescence signals onto the anatomical view, improving surgical decision-making and workflow efficiency.

The study will enroll 31 patients across at least two sites in the European Economic Area (EEA) and Switzerland. Eligible patients will undergo standard surgical procedures in the cerebral vascular area or plastic and reconstructive surgery. The study does not involve additional invasive procedures and is conducted entirely within the scope of routine care.

The primary objective is to assess the performance of GLOW800 in terms of fluorescence visibility and image quality. Secondary objectives include evaluating the continued safety of the device. Data will be collected using structured questionnaires completed by surgeons during and after surgery, along with video recordings captured by the microscope.

Endpoints include:

Primary: Fluorescence visibility (monochrome and pseudo-color), anatomical and fluorescence observations, vessel architecture, blood flow, capillary transition, drainage, stereoscopic perception, resolution, latency, and real-time blood flow visibility.

Secondary: Safety indicators such as dizziness, surgical interruptions, injuries, sterility breaches, and tissue burns.

The study duration is estimated at 5-6 months from first patient enrollment to completion. Each patient will participate in a single surgical procedure with no follow-up required.

Data will be pseudonymized and managed in compliance with GDPR and ISO 14155:2020. The study is sponsored by Leica Microsystems (Schweiz) AG and will be monitored according to standard clinical research practices.

The results will contribute to ongoing post-market surveillance and may support regulatory submissions, scientific publications, and future product development.

Вмешательства

• Устройство The GLOW800, a non-contact, non-invasive device, allows the surgical microscope ARveo 8 and ARveo 8X to produce excitation light and resolve fluorescence emission from the fluorescent agent ICG
  When activating the GLOW800 mode, the white light illumination of the Leica microscope stand is extended to InfraRed (IR), to excite the fluorophore (ICG). The technology provides ergonomic advantages as the user can maintain an upright posture while observing the surgical field. To excite the fluorophore, ICG dye is illuminated with light at its excitation wavelength band around 750 - 800nm. GLOW800 utilizes a 400w xenon illumination light source integrated as a standard component within the co

Первичные конечные точки

• Fluorescence visibility. [Срок оценки: Periprocedural]
• Image quality [Срок оценки: Periprocedural]
• Anatomical background [Срок оценки: Periprocedural]
• Visibility of real time vascular blood flow [Срок оценки: Periprocedural]

Вторичные конечные точки (1)

• The secondary objectives of this Post-Market Clinical Follow-up (PMCF) study are to assess the continued safety of the device. [Срок оценки: Postoperatively]

Критерии участия

Критерии включения

Candidates for the study must be appropriate patients for surgical interventions in the cerebral vascular area or for plastic and reconstructive surgery and have to fulfil all of 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.
• 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.
• 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

Критерии исключения

Candidates who meet any of the following exclusion criteria will not be eligible for recruitment in the study.

• Known allergy to Indocyanine Green (ICG) cyanine dye.
• Any uncontrolled systemic condition that may adversely affect the surgical outcome.
• Patients holding United States citizenship.
• 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

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Португалия · 1 центр

• Unidade Local de Saúde de São João — Porto

Испания · 1 центр

• Hospital Germans Trias I Pujol — Barcelona

Швейцария · 1 центр

• University Hospital Basel — Basel

Идентификаторы

NCT: NCT07164040 · GLOW800-PMCFSTUDYPLAN-202501

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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