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

Más betegség

• 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.

Egyéb

• Patients holding United States citizenship.

• 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.

A regiszterben nem jelölt feltételek

• 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.