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ClinicalTrials.gov ID

NCT07366892

Lead Sponsor

Leica Microsystems (Schweiz) AGINDUSTRY

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

37Estimated

Last Update Posted

Jan 26, 2026Actual

Start Date

Feb 1, 2026Estimated

Primary Completion Date

Dec 20, 2026Estimated

Completion Date

May 31, 2027Estimated

Official Title

Fluorescence Visualization and Image Quality Evaluation of Digital Visualization of Suspected Grade III and/or IV Gliomas During Neurosurgery (Leica GLOW400)

Brief Summary

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.

Detailed Description

The IMED-GLOW400 study is a prospective, observational, non-interventional clinical investigation conducted in the European Economic Area and Switzerland. It involves the use of the GLOW400 accessory, which digitally enhances fluorescence signals during neurosurgery, providing improved anatomical visualization and contrast. The study compares GLOW400 with the benchmark FL400 optical filter system.

The primary objective is to confirm the image quality and fluorescence visualization performance of GLOW400. Secondary objectives include validating product claims and assessing user experience and safety. An exploratory objective evaluates the extent of tumor resection using volumetric analysis of pre- and post-operative MRI scans.

Data will be collected through structured questionnaires, histopathology confirmation, optional resection forms, and intraoperative video recordings. The study will enroll 37 patients, with at least 29 complete datasets required for analysis. The duration of the study is estimated at 5 to 6 months, with each patient participating only during the surgical procedure.

The study complies with ISO 14155:2020, GDPR, and the Declaration of Helsinki. Ethics Committee approval and informed consent are mandatory prior to enrollment. No additional procedures beyond standard of care are introduced, and risks are limited to those associated with routine surgical practice.

• Suspected Grade III and IV Gliomas Requiring Surgical Intervention
• Neurosurgical Procedure
• Glioma
• Glioblastoma (GBM)

• GLOW400 is a digital surgical microscope accessory used in fluorescent visualization of suspected grade III or IV gliomas during neurosurgery.

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Inclusion Criteria

1. Participants must be 18 years of age or older at the time of signing the informed consent.
2. Participants must have suspected high-grade glioma (WHO grade III-IV) as evidenced by preoperative imaging modalities, which require surgical intervention.
3. The active substance 5-aminolevulinic acid (5-ALA) fluorescence dye is administered according to the 5-ALA 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.

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.

Exclusion Criteria

1. Known allergy to 5-ALA hydrochloride or protoporphyrin.
2. Patients with porphyria (a condition characterized by the inability to break down protoporphyrin).
3. Any uncontrolled systemic condition that may adversely affect the surgical outcome.
4. Patients holding United States citizenship.

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Leica Microsystems (Schweiz) AGINDUSTRY

raphael.guzman@usb.ch+41 61 265 33 68