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
38 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
- Able to undergo surgery within 72 hours after onset
- Glasgow Coma Scale (GCS) score between 5 and 14
- Ability to understand the study purpose and provide informed consent by the subject or their authorized representative
You will not qualify if you...
- History of intracerebral hemorrhage within the past year
- Traumatic intracerebral hemorrhage
- Multiple intracerebral hemorrhages (except those extending into ventricles in the supratentorial subcortical or basal ganglia region)
- Intracerebral hemorrhage caused by tumors, aneurysms, vascular malformations, hemorrhagic transformation of ischemic stroke, cerebral venous thrombosis, or similar causes
- Formation of brain herniation
- Severe neurological or psychiatric disorders before onset (e.g., epilepsy, Alzheimer's disease, Parkinson's disease, schizophrenia, depression)
- Modified Rankin Scale (mRS) score of 3 or higher before onset
- Use of anticoagulants or antiplatelet drugs within 14 days before onset, or need for long-term use, or other coagulation dysfunction factors
- Platelet count less than 100 x 10^3/μL or INR greater than 1.4
- Active bleeding such as gastrointestinal, respiratory, or subcutaneous hematoma
- Uncontrolled hypertension not manageable with medication (SBP > 220 mmHg or DBP > 120 mmHg after medication upon admission)
- Severe systemic diseases intolerant to surgery (e.g., severe liver or kidney dysfunction)
- Pregnant or breastfeeding women of childbearing age
- Current participation or planned participation in other drug or device clinical trials
- Life expectancy of 1 year or less
- Other conditions deemed unsuitable by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Actively Recruiting
Research Team
H
Huina Lu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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