Actively Recruiting
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.
Led by Leica Microsystems (Schweiz) AG · Updated on 2026-01-20
29
Participants Needed
3
Research Sites
79 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years of age or older at the time of signing the informed consent.
- Participants must need surgical intervention in the cerebral vascular area or plastic and reconstructive surgery.
- Indocyanine Green (ICG) dye is administered as a contrast agent according to instructions.
- Participant or legal representative must understand the study and have voluntarily signed the approved informed consent form.
You will not qualify if you...
- Known allergy to Indocyanine Green (ICG) dye.
- Any uncontrolled systemic condition that may negatively affect the surgical outcome.
- Patients who are United States citizens.
- Severe iodine-induced reactions to iodine-containing compounds, especially with anaphylaxis or respiratory problems.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Unidade Local de Saúde de São João
Porto, Portugal
Actively Recruiting
2
Hospital Germans Trias I Pujol
Barcelona, Spain
Not Yet Recruiting
3
University Hospital Basel
Basel, Switzerland
Not Yet Recruiting
Research Team
D
Daniela Leal
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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