Status:
RECRUITING
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.
Lead Sponsor:
Leica Microsystems (Schweiz) AG
Conditions:
Reconstructive Surgical Procedures
Plastic Surgery
Eligibility:
All Genders
18+ years
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. ...
Detailed Description
The IMED-GLOW800 study is designed to collect clinical data on the GLOW800 device, a CE-marked surgical microscope accessory developed by Leica Microsystems. The device enables enhanced intraoperative...
Eligibility Criteria
Inclusion
- 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.
- 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
- Candidates who meet any of the following exclusion criteria will not be eligible for recruitment in the study.
- 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.
Key Trial Info
Start Date :
November 30 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 30 2027
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT07164040
Start Date
November 30 2025
End Date
July 30 2027
Last Update
November 25 2025
Active Locations (3)
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1
Unidade Local de Saúde de São João
Porto, Portugal
2
Hospital Germans Trias I Pujol
Barcelona, Spain
3
University Hospital Basel
Basel, Switzerland