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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Using a disposable intracerebral aspiration endoscope to remove the intracerebral hematoma
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
RECRUITINGIntracerebral 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.
Time frame: Day 0(within 24 hours after procedure)
Hospitalization duration
Time frame: During the days at hospital(up to 105 days)
Intensive Care Unit(ICU) duration
Time frame: During the days at Intensive Care Unit(ICU)(up to 105 days)
The proportion of subjects with an mRS score of ≤3 at 3 months after surgery
Time frame: 3 months after surgery(±15days)
The incidence of rebleeding at the surgical site within 7 days after surgery or before discharge.
Time frame: 7 days (±1day) after surgery or before discharge.
The incidence of reoperation due to rebleeding at the surgical site during the follow-up period.
Time frame: 3 months after surgery(±15days)
All-cause mortality
Time frame: 3 months after surgery(±15days)
Device-related SAE
Time frame: 3 months after surgery(±15days)
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