Condition: Intracerebral Hemorrhage · Sponsor: MicroPort NeuroTech Co., Ltd.
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.
This description comes directly from the study's public registry record.
Huina Lu · 021-38954600 · HuiNa.Lu@microport.com
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| Affiliated Hospital of Guizhou Medical University | Guiyang, Guizhou, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06843616