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A PILOT TRIAL of a DISPOSABLE INTRACEREBRAL ASPIRATION ENDOSCOPE for the TREATMENT of INTRACEREBRAL HEMATOMA(FAST-HET)
Sponsor: MicroPort NeuroTech Co., Ltd.
Summary
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.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
16
Start Date
2025-02-06
Completion Date
2025-10-31
Last Updated
2025-02-25
Healthy Volunteers
No
Conditions
Interventions
Endoscopic surgery
Using a disposable intracerebral aspiration endoscope to remove the intracerebral hematoma
Locations (1)
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China