Overview
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.
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.
Eligibility
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
- 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.
Exclusion Criteria
- 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.
- Patients holding United States citizenship.
