This clinical trial is a prospective, open-label, single-arm clinical trial. According to the inclusion and exclusion criteria specified in the trial protocol, no fewer than 16 subjects with cerebral hemorrhage will be enrolled in 1 to 2 clinical centers. Considering the learning period required for doctor to become proficient in using the device, the first three cases at each research center are considered as the lead-in period cases and will not be included in the primary analysis dataset. During the surgery, a disposable intracerebral aspiration endoscope will be used to remove the intracerebral hematoma. Follow-ups will be conducted at discharge/Day 7 (±1 day), postoperative 1 month (±7 days), and postoperative 3 months (±15 days). Recording various indicators to evaluate the safety and effectiveness of the disposable intracerebral aspiration endoscope in treating intracerebral hematoma.
Age ≥ 18 and ≤ 80 years old;
Spontaneous intracerebral hemorrhage;
Hemorrhage located in the supratentorial subcortical or basal ganglia region;
Hematoma volume ≥ 30ml and ≤ 80ml;
History of intracerebral hemorrhage within the past year;
Traumatic intracerebral hemorrhage;
Multiple intracerebral hemorrhages;
Known or suspected intracerebral hemorrhage caused by tumors, aneurysms, vascular malformations, hemorrhagic transformation of ischemic stroke, cerebral venous thrombosis, etc.;
Single group
Endoscopic surgery
Procedure/SurgeryUsing a disposable intracerebral aspiration endoscope to remove the intracerebral hematoma
Intracerebral hematoma clearance rate
Perform a brain CT scan within 24 hours after surgery, comparing it with the baseline CT, and calculating the proportion of hematoma volume reduction.
Hospitalization duration
Intensive Care Unit(ICU) duration
The proportion of subjects with an mRS score of ≤3 at 3 months after surgery
The incidence of rebleeding at the surgical site within 7 days after surgery or before discharge.
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