NCT07366892Recruiting
Leica Microsystems Sponsored PMCF Study to Collect and Confirm Clinical Data on the Performance of the GLOW400 Device When Used in Accordance With Its Intended Use
Fluorescence Visualization and Image Quality Evaluation of Digital Visualization of Suspected Grade III and/or IV Gliomas During Neurosurgery (Leica GLOW400)
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
This post-market clinical follow-up (PMCF) study aims to confirm the safety and performance of the GLOW400 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 neurosurgery. It is a non-interventional, observational study conducted in routine care settings across multiple European sites.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 37 (estimated)
- First submitted
- 7 Jan 2026
- Start date
- 28 Apr 2026
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- Leica Microsystems (Schweiz) AG
- Diseases
- Glioblastoma
- NCT number
- NCT07366892
What you commit to
- Study type: Observational
- Planned participants: 37
- From 28 Apr 2026 to the primary completion date, 28 Feb 2027
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known allergy to 5-ALA hydrochloride or protoporphyrin.
- Patients with porphyria (a condition characterized by the inability to break down protoporphyrin).
- Any uncontrolled systemic condition that may adversely affect the surgical outcome.
Other
- Patients holding United States citizenship.
Who the study is looking for
- Participants must be 18 years of age or older at the time of signing the informed consent.
- Participants must have suspected high-grade glioma (WHO grade III-IV) as evidenced by preoperative imaging modalities, which require surgical intervention.
- The active substance 5-aminolevulinic acid (5-ALA) fluorescence dye is administered according to the 5-ALA 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.
- Note for Switzerland only:
- Enrollment via legal representative is not permitted. Therefore, only patients who are capable of providing informed consent themselves will be eligible for inclusion in Switzerland.
Criteria the registry did not label
- Candidates for the for the IMED-GLOW400 Study must be appropriate patients for surgical interventions with suspected intracranial high-grade glioma evidenced by preoperative imaging modalities and have to fulfil all of the following inclusion criteria to be eligible for the recruitment of the study.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Recruiting |
| Unidade Local de Saúde de São João Coordinator of this site? Confirm its status | Porto | Portugal | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.