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.

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.

NCT Number	NCT07164040
Lead Sponsor	Leica Microsystems (Schweiz) AG
Conditions	Reconstructive Surgical Procedures, Plastic Surgery, Vascular Surgical Procedure, Cerebrovascular Disorder
Enrollment	29 participants
Start Date	2026-01-20
Primary Completion	2026-12-31 (estimated)
Study Completion	2027-07-30 (estimated)
Updated on ClinicalTrials.gov	2026-01-20