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.

Not yet recruitingOBSERVATIONAL
Enrollment

29

Participants

Timeline

Start Date

November 1, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

July 30, 2027

Conditions
Reconstructive Surgical ProceduresPlastic SurgeryVascular Surgical ProcedureCerebrovascular Disorder
Interventions
DEVICE

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

When activating the GLOW800 mode, the white light illumination of the Leica microscope stand is extended to InfraRed (IR), to excite the fluorophore (ICG). The technology provides ergonomic advantages as the user can maintain an upright posture while observing the surgical field. To excite the fluorophore, ICG dye is illuminated with light at its excitation wavelength band around 750 - 800nm. GLOW800 utilizes a 400w xenon illumination light source integrated as a standard component within the compatible Surgical Operating Microscope (SOM) stand. Activation of the GLOW800 mode extends the white light illumination of the SOM to the infrared (IR) spectral range using a suitable filter placed in the compatible SOM's standard filter wheel for the excitation of the ICG. Each patient enrolled in this study will undergo standard of care for the surgical procedure. No deviations to the standard of care will occur in the execution of this study.

Trial Locations (3)

Unknown

Unidade Local de Saúde de São João, Porto

Hospital Germans Trias I Pujol, Barcelona

University Hospital Basel, Basel

All Listed Sponsors
lead

Leica Microsystems (Schweiz) AG

INDUSTRY

NCT07164040 - 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. | Biotech Hunter | Biotech Hunter