Pilot Study of a Disposable Intracerebral Aspiration Endoscope for Treating Intracerebral Hematoma in Adults Aged 18 to 80

What this Trial Is About

Researchers are evaluating the use of a disposable intracerebral aspiration endoscope to treat patients with intracerebral hemorrhage, a type of brain bleeding. This open-label, single-arm clinical trial will enroll at least 16 participants with cerebral hemorrhage and aims to assess the safety and effectiveness of this device during surgery. The study excludes the first three cases at each center as part of a learning period for doctors to become proficient with the device. During the surgery, the disposable intracerebral aspiration endoscope will be used to remove the hematoma from the brain. Follow-up visits will occur at discharge or day 7 1 day, 1 month post-surgery 7 days, and 3 months post-surgery 15 days to monitor recovery and gather data. The trial focuses on measuring the hematoma clearance rate within 24 hours after the procedure and tracks other outcomes such as hospitalization time, ICU duration, rebleeding events, reoperations, mortality, and device-related serious adverse events. Participants will undergo surgery using the device and attend scheduled follow-up visits for evaluations, including clinical assessments and safety monitoring. Researchers will collect various indicators to evaluate treatment effects and track patient outcomes up to 3 months after surgery. This process involves detailed recording of recovery progress and any complications to better understand the role of this endoscopic technique in treating intracerebral hematoma.

A PILOT TRIAL of a DISPOSABLE INTRACEREBRAL ASPIRATION ENDOSCOPE for the TREATMENT of INTRACEREBRAL HEMATOMA（FAST-HET）