Fluorescence Visualization and Image Quality Evaluation of Digital Visualization During Standard Surgical Procedures in the Cerebral Vascular Area and Plastic and Reconstructive Surgery Using the Leica GLOW800 Device

What this Trial Is About

Researchers are evaluating the GLOW800 surgical microscope accessory to confirm its safety and performance when used with the ARveo8x surgical microscope during standard surgeries in the cerebral vascular area and plastic and reconstructive surgery. This observational post-market clinical follow-up study focuses on how well the device enhances fluorescence visualization and image quality to support surgical decisions. The study is conducted in routine care settings at multiple European sites without additional invasive procedures. The GLOW800 device digitally overlays real-time fluorescence signals onto the anatomical surgical view, improving workflow by eliminating the need to switch views during surgery. It uses infrared light to excite the fluorescent agent Indocyanine Green (ICG) and provides stereoscopic depth perception. Patients will undergo their standard surgical procedure with the GLOW800 accessory active, and surgeons will capture video and complete structured questionnaires about fluorescence visibility, image quality, and blood flow during surgery. Participants will be involved in a single surgical procedure with no follow-up visits required. Data collection includes surgeon assessments and video recordings during surgery, focusing on fluorescence visibility, anatomical background, vessel structure, and real-time blood flow. Safety will be monitored by tracking any dizziness, surgical interruptions, injuries, sterility issues, or tissue burns. The study duration per patient is limited to the surgery period, with data handled according to privacy standards and the overall study expected to last 5-6 months from first enrollment to completion.

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.