Brain surgery such as hypertensive cerebral hemorrhage and brain tumors
Conditions
Interventions
exprimental group:exprimental production
control group:control production
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years males or females; 2. Brain surgery patients with hypertensive cerebral hemorrhage, brain tumor and so on who are diagnosed by imaging examination (CT or MRI); 3. Patients or guardians agree to participate the trial and sign informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with late stage of cerebral hernia; 2. Patients with aneurysm or cerebral arteriovenous malformation; 3. Patients with cardiac arrest caused by craniocerebral trauma, or patients with bilateral mydriasis and unstable vital signs caused by severe craniocerebral trauma; 4. Patients with inflammation in the operation area; 5. Patients allergic to known materials (polycarbonate, acrylonitrile butadiene styrene copolymer, cycloolefin polymer and 304 stainless steel); 6. Lactating women and pregnant women; 7. Patient had participated in clinical studies of other drugs or devices within 3 months before signing the informed consent (excluding registered Studies); 8. Patient who is judged ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comprehensive score of clinical effect; | — |
Secondary
| Measure | Time frame |
|---|---|
| Performance evaluation of device;Incidence of brain retraction injury; | — |
Countries
China
Contacts
Public ContactChen Liang
Huashan Hospital,Fudan University
Outcome results
None listed