Confirming the GLOW800 microscope accessory's performance with the ARveo8X surgical microscope.
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)
This project tests whether the GLOW800 microscope accessory helps surgeons see blood flow and improves image quality during adult cerebral vascular and plastic/reconstructive surgeries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 29 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leica Microsystems (Schweiz) AG Industry-sponsored |
| Locations | 3 sites (Porto and 2 other locations) |
| Trial ID | NCT07164040 on ClinicalTrials.gov |
What this trial studies
This post-market clinical follow-up is an observational, non-interventional study collecting routine-care data on the CE‑marked GLOW800 microscope accessory used with the ARveo8X microscope. The device overlays Indocyanine Green (ICG) fluorescence onto the anatomical view in real time to improve visualization of blood flow without switching views. Up to 31 adult patients undergoing cerebral vascular or plastic and reconstructive surgery will be enrolled across several European sites, with no additional invasive procedures beyond standard care. Primary endpoints are fluorescence visibility and image quality as rated by surgeons, with secondary monitoring of device safety using structured questionnaires and microscope video recordings.
Who should consider this trial
Good fit: Adults (≥18 years) scheduled for cerebral vascular or plastic/reconstructive surgery where ICG will be used and who can give informed consent are ideal candidates.
Not a fit: Patients who are pediatric, who will not receive ICG, or who have known contraindications or allergy to ICG are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the device could help surgeons make quicker, more confident decisions by improving intraoperative visualization of blood flow and streamlining workflow.
How similar studies have performed: ICG fluorescence imaging and overlay technologies have been used in other surgical settings and reported improved visualization, and the GLOW800 is CE‑marked though this PMCF collects additional real‑world confirmation.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Porto and 2 other locations
- Unidade Local de Saúde de São João — Porto, Portugal (Recruiting)
- Hospital Germans Trias I Pujol — Barcelona, Spain (Not_yet_recruiting)
- University Hospital Basel — Basel, Switzerland (Not_yet_recruiting)
Study contacts
- Study coordinator: Daniela Leal
- Email: clinical.affairs@leica-microsystems.com
- Phone: +41793741989
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.