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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.

Recruitingn/aAges 18 Years - anyAllLeica Microsystems (Schweiz) AG
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 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. 1. Participants must be 18 years of age or older at the time of signing the informed consent. 2. Participants must have a condition requiring surgical intervention in the cerebral vascular area as well as during plastic and reconstructive surgery. 3. The Indocyanine Green (ICG) cyanine dye is administered as a contrast agent per instructions for use. 4. 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 Exclusion Criteria: Candidates who meet any of the following exclusion criteria will not be eligible for recruitment in the study. 1. Known allergy to Indocyanine Green (ICG) cyanine dye. 2. Any uncontrolled systemic condition that may adversely affect the surgical outcome. 3. Patients holding United States citizenship. 4. 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.
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What it tests

  • 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
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Where

3 sites
Unidade Local de Saúde de São João
Porto, Portugal
Hospital Germans Trias I Pujol
Barcelona, Spain
University Hospital Basel
Basel, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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