Leica Microsystems Sponsored PMCF Study to Collect and Confirm Clinical Data on the Performance of the GLOW400 Device When Used in Accordance With Its Intended Use

Sponsor
Leica Microsystems (Schweiz) AG
Study ID
NCT07366892
Status
Not Yet Recruiting

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Conditions

  • Glioblastoma (GBM)
  • Glioma
  • Neurosurgical Procedure
  • Suspected Grade III and IV Gliomas Requiring Surgical Intervention

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GLOW400 is a digital surgical microscope accessory used in fluorescent visualization of suspected grade III or IV gliomas during neurosurgery. — DEVICE
    The digital surgical microscope accessory GLOW400 is using the optical excitation and emission filtering of the FL400. The FL400 provides an illumination filter (380nm - 430nm) which when engaged into the light source path of the surgical operating microscope provides, via a light guide, a fluorescence excitation light system used in conjunction with an approved tumor-selective substance (fluorophore) (e.g. Protoporphyrin IX (PpIX) which is resulting of the metabolization of 5-ALA (5 - aminolaevulinic acid)) for tissue characterization in the open neurosurgery field. PpIX is strongly fluorescent with a peak at λ=635 nm as red-violet after excitation with blue light (λ=380-410 nm). The digital surgical microscope accessory GLOW400 is using the optical excitation and emission filtering of the FL400. The fluorescence signal visualized depicts the distribution of the dye in the patient's tissues during the surgical procedure.

Study Details

This post-market clinical follow-up (PMCF) study aims to confirm the safety and performance of the GLOW400 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 neurosurgery. It is a non-interventional, observational study conducted in routine care settings across multiple European sites.

Key Dates

First listed
Jan 26, 2026
Start date
Feb 1, 2026
Status verified
Jan 2026
Primary completion
Dec 20, 2026
Completion
May 31, 2027

Study Design

Enrollment
37 participants (estimated)

Arms

  • Arm: GLOW400

Primary Outcome Measure

Flourescence visibility [ Time Frame: Periprocedural ]

Central Contacts

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