Actively Recruiting
A Pilot Trial of a Disposable Intracerebral Aspiration Endoscope for the Treatment of Intracerebral Hematoma (FAST-HET)
Led by MicroPort NeuroTech Co., Ltd. · Updated on 2025-02-25
16
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
A PILOT TRIAL of a DISPOSABLE INTRACEREBRAL ASPIRATION ENDOSCOPE for the TREATMENT of INTRACEREBRAL HEMATOMA（FAST-HET）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years old
- Diagnosis of spontaneous intracerebral hemorrhage
- Hemorrhage located in the supratentorial subcortical or basal ganglia region
- Hematoma volume between 30 ml and 80 ml
- Ability to undergo surgery within 72 hours after onset
- Glasgow Coma Scale (GCS) score between 5 and 14
- Participant or authorized representative can understand and agree to the study, and sign informed consent
You will not qualify if you...
- History of intracerebral hemorrhage within the past year
- Traumatic intracerebral hemorrhage
- Multiple intracerebral hemorrhages (except hemorrhage extending into ventricles in specified regions)
- Intracerebral hemorrhage caused by tumors, aneurysms, vascular malformations, ischemic stroke transformation, cerebral venous thrombosis, or similar
- Presence of brain herniation
- Severe neurological or psychiatric disorders before onset
- Modified Rankin Scale (mRS) score of 3 or higher before onset
- Use of anticoagulants or antiplatelet drugs within 14 days before onset or long-term use causing coagulation dysfunction
- Platelet count less than 100 x 10^3/μL or INR greater than 1.4
- Active bleeding such as gastrointestinal, respiratory, or subcutaneous bleeding
- Uncontrolled hypertension not manageable by medication
- Severe systemic diseases intolerant to surgery
- Pregnant or breastfeeding women of childbearing age
- Participation in other drug or device clinical trials
- Life expectancy less than or equal to 1 year
- Other conditions deemed unsuitable by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 days or until discharge
Participants undergo endoscopic surgery using a disposable intracerebral aspiration endoscope to remove the intracerebral hematoma, followed by immediate post-operative care.
Daily visits while hospitalized
Duration - 3 months (±15 days)
Participants are monitored for recovery, rebleeding, and other outcomes for up to 3 months after surgery.
1 visit at approximately 3 months after surgery
Trial Site Locations
Total: 1 location
1
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Actively Recruiting
Research Team
H
Huina Lu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here