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

NCT07366892 | Not Yet Recruiting

• 1 other identifier: GLOW400-PMCFSTUDYPLAN-202501
• Study Type: observational
• Target: 37
• Locations: 2 countries
• Sites: 2

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.

Conditions

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

Keywords

GLOW400; ARveo8x; Digital surgical microscope; 5-ALA fluorescence; Image quality assessment; Grade III gliomas; Grade IV gliomas; High-grade glioma; fluorescence-guided surgery

Outcome Measures

Primary Outcomes (3)

• Flourescence visibility

  Performance will be evaluated using Questionnaire, a structured Likert-scale survey completed by the operating surgeon during and after surgery. The questionnaire assesses: 1. perceived intensity of fluorescence 2. perceived volume/ shape and relative location 3. perceived distribution of fluorescence 4. anatomical and fluorescence observation (GLOW400 Anatomy only) Each item is rated on a 5-point Likert scale: 1. = Not available 2. = Insufficient 3. = Sufficient 4. = Very good 5. = Excellent Higher scores indicate better performance. The outcome is considered acceptable if all ratings are ≥3 (Sufficient or better).

  Periprocedural

• Image quality

  Performance will be evaluated using Questionnaire, a structured Likert-scale survey completed by the operating surgeon during and after surgery. The questionnaire assesses:: 1. Stereoscopic Perception (3D Depth perception) 2. Resolution 3. Noise 4. Latency Each item is rated on a 5-point Likert scale: 1. = Not available 2. = Insufficient 3. = Sufficient 4. = Very good 5. = Excellent Higher scores indicate better performance. The outcome is considered acceptable if all ratings are ≥3 (Sufficient or better).

  Periprocedural

• Anatomy of the brain, including Vessels (GLOW400 Anatomy only)

  Performance will be evaluated using Questionnaire, a structured Likert-scale survey completed by the operating surgeon during and after surgery. The questionnaire assesses: 1. Neuroanatomy structures 2. Vascular structures 4. Perceived contrast (GLOW400 HiFluo only) 5. Bleeding visibility (GLOW400 Anatomy only) 6. Traces of remaining fluorescence (GLOW400 HiFluo only) Each item is rated on a 5-point Likert scale: 1. = Not available 2. = Insufficient 3. = Sufficient 4. = Very good 5. = Excellent Higher scores indicate better performance. The outcome is considered acceptable if all ratings are ≥3 (Sufficient or better).

  Periprocedural

Secondary Outcomes (1)

• The secondary objectives of this Post-Market Clinical Follow-up (PMCF) study are to assess the continued safety of the device.

  Postoperatively

Other Outcomes (1)

• Assessment of the extent of tumor resection

  Postoperatively

Study Arms (1)

GLOW400

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

Interventions

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

The digital surgical microscope accessory GLOW400 is using the optical excitation and emission filtering of the FL400. The FL400 provides an illumination filter (380nm - 430nm) which when engaged into the light source path of the surgical operating microscope provides, via a light guide, a fluorescence excitation light system used in conjunction with an approved tumor-selective substance (fluorophore) (e.g. Protoporphyrin IX (PpIX) which is resulting of the metabolization of 5-ALA (5 - aminolaevulinic acid)) for tissue characterization in the open neurosurgery field. PpIX is strongly fluorescent with a peak at λ=635 nm as red-violet after excitation with blue light (λ=380-410 nm). The digital surgical microscope accessory GLOW400 is using the optical excitation and emission filtering of the FL400. The fluorescence signal visualized depicts the distribution of the dye in the patient's tissues during the surgical procedure.

GLOW400

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient population will include patients with suspected grade III or IV gliomas requiring surgical intervention, and who meet the Inclusion/Exclusion Criteria for the IMED-GLOW400 Study.

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Leica Microsystems (Schweiz) AG: lead

Study Sites (2)

Unidade Local de Saúde de São João

Porto, Portugal

Location

University Hospital Basel

Basel, Switzerland

Location

MeSH Terms

Conditions

Glioma; Glioblastoma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Astrocytoma

Central Study Contacts

Daniela Leal

CONTACT

+41793741989; daniela.leal@leica-microsystems.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 26, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

PT (1); CH (1)