NCT07164040 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.
| NCT ID | NCT07164040 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Leica Microsystems (Schweiz) AG |
| Condition | Reconstructive Surgical Procedures |
| Study Type | OBSERVATIONAL |
| Enrollment | 31 participants |
| Start Date | 2026-01-08 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 31 participants in total. It began in 2026-01-08 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07164040 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Reconstructive Surgical Procedures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07164040 currently recruiting?
Yes, NCT07164040 is actively recruiting participants. Contact the research team at clinical.affairs@leica-microsystems.com for enrollment information.
Where is the NCT07164040 trial being conducted?
This trial is being conducted at Porto, Portugal, Barcelona, Spain, Basel, Switzerland.
Who is sponsoring the NCT07164040 clinical trial?
NCT07164040 is sponsored by Leica Microsystems (Schweiz) AG. The trial plans to enroll 31 participants.