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IMED-GLOW400NCT07366892

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

StatusRecruiting
PhaseNot specified
Primary completion (estimated)

At risk: Primary completion moved at least 2 months later.

See at-risk trials from Leica Microsystems (Schweiz) AG

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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

  1. Recruitment opened Show 6 more changesShow less
    • Primary completion pushed from Dec 20, 2026 to Feb 28, 2027
    • Study completion pushed from May 31, 2027 to Aug 31, 2027
    • Start date changed from estimate of Feb 1, 2026 to Apr 28, 2026
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised at 2 of 2 sites
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Flourescence visibility
Timeframe: Periprocedural
Image quality
Timeframe: Periprocedural
Anatomy of the brain, including Vessels (GLOW400 Anatomy only)
Timeframe: Periprocedural

Secondary (1)

The secondary objectives of this Post-Market Clinical Follow-up (PMCF) study are to assess the continued safety of the device.

Arms and interventions

GLOW400

Devices: GLOW400 is a digital surgical microscope accessory used in fluorescent visualization of suspected grade III or IV gliomas during neurosurgery.

Sites

2 sites in 2 countries

Portugal 1, Switzerland 1