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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.

NCT07164040 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 29

Last updated 2026-01-20

No results posted yet for this study

Summary

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

  • Reconstructive Surgical Procedures
  • Plastic Surgery
  • Vascular Surgical Procedure
  • Cerebrovascular 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.

Sponsors & Collaborators

  • Leica Microsystems (Schweiz) AG

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-20
Primary Completion
2026-12-31
Completion
2027-07-30

Countries

  • Portugal
  • Spain
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07164040 on ClinicalTrials.gov