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IMED-GLOW800NCT07164040

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.

StatusRecruiting
PhaseNot specified
Primary completion (estimated)
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Record History

All 5 versions: 5 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary completion moved earlier from Dec 31, 2026 to Nov 30, 2026 Show 5 more changesShow less
    • Enrollment target: 29 to 31
    • Start date changed from estimate of Jan 20, 2026 to Jan 8, 2026
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised at 2 of 3 sites
  2. Start date: Nov 30, 2025 to Jan 20, 2026v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Nov 1, 2025 to Nov 30, 2025
    • Site details revised at 3 of 3 sites
    v3
  4. Start date: Sep 15, 2025 to Nov 1, 2025
    • Site contacts updated at 1 of 3 sites
    • Study title shortened, about 1 word
    v2
  5. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Fluorescence visibility.
Timeframe: Periprocedural
Image quality
Timeframe: Periprocedural
Anatomical background
Timeframe: Periprocedural
Visibility of real time vascular blood flow
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

GLOW800

Devices: 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

Sites

3 sites in 3 countries

Portugal 1, Spain 1, Switzerland 1