RecruitingNot Applicable

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.

Portugal, Spain, Switzerland29 participantsStarted 2026-01-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participants must be 18 years of age or older at the time of signing the informed consent.
✓. Participants must have a condition requiring surgical intervention in the cerebral vascular area as well as during plastic and reconstructive surgery.
✓. The Indocyanine Green (ICG) cyanine dye is administered as a contrast agent per instructions for use.
✓. The participant or their legal representative must understand the study and have voluntarily signed and dated the Informed Consent Form, which has been approved by the Sponsor and the Ethics Committee for this study

Exclusion criteria

✕. Known allergy to Indocyanine Green (ICG) cyanine dye.
✕. Any uncontrolled systemic condition that may adversely affect the surgical outcome.
✕. Patients holding United States citizenship.
✕. Severe iodine-induced reactions to macromolecular iodine-containing compounds (e.g., iodinated contrast media, iodine-based antiseptics, or drugs like amiodarone), especially if the reaction involved anaphylaxis or respiratory compromise.

What they're measuring

Fluorescence visibility.

Timeframe: Periprocedural

Image quality

Timeframe: Periprocedural

Anatomical background

Timeframe: Periprocedural

Visibility of real time vascular blood flow

Timeframe: Periprocedural

Trial details

NCT IDNCT07164040

SponsorLeica Microsystems (Schweiz) AG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-12-31

Contact for this trial

Daniela Leal

+41793741989 clinical.affairs@leica-microsystems.com

View on ClinicalTrials.gov More Reconstructive Surgical Procedures trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participants must be 18 years of age or older at the time of signing the informed consent.
✓. Participants must have a condition requiring surgical intervention in the cerebral vascular area as well as during plastic and reconstructive surgery.
✓. The Indocyanine Green (ICG) cyanine dye is administered as a contrast agent per instructions for use.
✓. The participant or their legal representative must understand the study and have voluntarily signed and dated the Informed Consent Form, which has been approved by the Sponsor and the Ethics Committee for this study

Exclusion criteria

✕. Known allergy to Indocyanine Green (ICG) cyanine dye.
✕. Any uncontrolled systemic condition that may adversely affect the surgical outcome.
✕. Patients holding United States citizenship.
✕. Severe iodine-induced reactions to macromolecular iodine-containing compounds (e.g., iodinated contrast media, iodine-based antiseptics, or drugs like amiodarone), especially if the reaction involved anaphylaxis or respiratory compromise.