A PILOT TRIAL of a DISPOSABLE INTRACEREBRAL ASPIRATION ENDOSCOPE for the TREATMENT of INTRACEREBRAL HEMATOMA（FAST-HET）
Recruiting now · Not applicable
Conditions studied: Intracerebral Hemorrhage
In brief
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 facts
- Study ID
- NCT06843616
- Run by
- MicroPort NeuroTech Co., Ltd.
- People needed
- 16
- Starts
- 2025-02-06
- Expected to finish
- 2025-10-31
- Last updated by the study team
- 2025-02-25
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 and ≤ 80 years old;
- Spontaneous intracerebral hemorrhage;
- Hemorrhage located in the supratentorial subcortical or basal ganglia region;
- Hematoma volume ≥ 30ml and ≤ 80ml;
- Able to undergo surgery within 72 hours after onset;
- GCS score of 5 to 14;
- The subject themselves and/or their authorized representative can understand the purpose of the study, agree to participate, and sign the informed consent form.
You may not qualify if…
- History of intracerebral hemorrhage within the past year;
- Traumatic intracerebral hemorrhage;
- Multiple intracerebral hemorrhages;
- Note: Hemorrhage in the supratentorial subcortical or basal ganglia region that extends into the ventricles is not considered multiple hemorrhages and can be included.
- Known or suspected intracerebral hemorrhage caused by tumors, aneurysms, vascular malformations, hemorrhagic transformation of ischemic stroke, cerebral venous thrombosis, etc.;
- Formation of brain herniation;
- Severe neurological or psychiatric disorders before onset (such as epilepsy, Alzheimer's disease, Parkinson's disease, schizophrenia, depression, etc.);
- mRS score ≥ 3 before onset;
- Use of anticoagulants or antiplatelet drugs within 14 days before onset, or the need for long-term use of anticoagulants or antiplatelet drugs, or other factors causing coagulation dysfunction;
- Platelet count less than 100 × 10\^3/μL or international normalized ratio (INR) greater than 1.4;
- Active bleeding present, such as gastrointestinal bleeding, respiratory bleeding, or subcutaneous hematoma;
- Uncontrolled hypertension that cannot be managed with medication (systolic blood pressure > 220 mmHg or diastolic blood pressure > 120 mmHg after medication upon admission);
- Severe systemic diseases that cannot tolerate surgery, such as severe liver or kidney dysfunction;
- Women of childbearing age who are pregnant or breastfeeding;
- Currently participating in any drug or device research, or planning to participate in other drug or device clinical trials;
- Life expectancy ≤ 1 year;
- Other situations where the researcher deems the subject unsuitable for the study.
Where it is running
- Affiliated Hospital of Guizhou Medical University — Guiyang, Guizhou, China (enrolling)
Full record on ClinicalTrials.gov
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