Confirming the GLOW800 microscope accessory's performance with the ARveo8X surgical microscope.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This post-market clinical follow-up is an observational, non-interventional study collecting routine-care data on the CE‑marked GLOW800 microscope accessory used with the ARveo8X microscope. The device overlays Indocyanine Green (ICG) fluorescence onto the anatomical view in real time to improve visualization of blood flow without switching views. Up to 31 adult patients undergoing cerebral vascular or plastic and reconstructive surgery will be enrolled across several European sites, with no additional invasive procedures beyond standard care. Primary endpoints are fluorescence visibility and image quality as rated by surgeons, with secondary monitoring of device safety using structured questionnaires and microscope video recordings.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Candidates for the study must be appropriate patients for surgical interventions in the cerebral vascular area or for plastic and reconstructive surgery and have to fulfil all of the following inclusion criteria to be eligible for the recruitment of the study.

1. Participants must be 18 years of age or older at the time of signing the informed consent.
2. Participants must have a condition requiring surgical intervention in the cerebral vascular area as well as during plastic and reconstructive surgery.
3. The Indocyanine Green (ICG) cyanine dye is administered as a contrast agent per instructions for use.
4. 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:

Candidates who meet any of the following exclusion criteria will not be eligible for recruitment in the study.

1. Known allergy to Indocyanine Green (ICG) cyanine dye.
2. Any uncontrolled systemic condition that may adversely affect the surgical outcome.
3. Patients holding United States citizenship.
4. 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.

Where it's running

• Unidade Local de Saúde de São João
  Porto, Portugal Recruiting
• Hospital Germans Trias I Pujol
  Barcelona, Spain Recruiting
• University Hospital Basel
  Basel, Switzerland Recruiting

Study contacts

• Study coordinator: Daniela Leal
• Email: clinical.affairs@leica-microsystems.com
• Phone: +41793741989

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.