Glioma
Conditions
Interventions
Index test:Innovative intraoperative handheld microscope - EndoScell (ES) system
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Age 18 to 65 years, gender not specified; 2.Clinically and radiologically diagnosed with gliomatosis cerebri; 3.Patients scheduled to undergo resection surgery for gliomatosis cerebri; 4.Patients comply with the standard postoperative treatment protocol for glioma; 5.Patients voluntarily participate in this study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients who have undergone radiotherapy or chemotherapy prior to surgery; 2.Patients with severe cardiovascular or circulatory system diseases who cannot tolerate surgery; 3.Patients who have participated in other investigational drug or device clinical trials within the last month; 4.Patients who are unable to understand the trial requirements or cannot complete the study follow-up plan; 5.Pregnant or breastfeeding women; 6.Patients unable to complete the follow-up due to psychiatric diseases, cognitive or emotional disorders; 7.Subjects deemed unsuitable for participation in the study by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness: Comparison of consistency with tissue section staining;Satisfaction with ES imaging;Quality of Life; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event rate;Overall survival rate;Modified Rankin Scale (mRS);recurrence rates;Progression-Free Survival;Consistency between ES interpretation and histopathological diagnosis; | — |
Countries
China
Contacts
Public ContactYongping You
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed