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

Launched by MICROPORT NEUROTECH CO., LTD. · Feb 21, 2025

Keywords

ClinConnect Summary

This clinical trial, called FAST-HET, is looking at a new device called a disposable intracerebral aspiration endoscope, which is designed to help treat a condition known as intracerebral hemorrhage. This condition occurs when there is bleeding inside the brain, which can be very serious. The trial aims to see how safe and effective this new device is in removing blood from the brain to help patients recover. To participate, individuals must be between 18 and 80 years old, have a certain type of brain bleed (with specific volume requirements), and be able to undergo surgery within 72 hours of the bleed starting.

Participants in the trial will receive surgery using the new device, and they will be followed up at various times after the procedure to monitor their recovery. This includes check-ins at the hospital discharge, one month later, and three months later. It's important to know that certain health conditions or treatments may exclude someone from participating, such as severe bleeding disorders, uncontrolled high blood pressure, or ongoing use of certain medications. The trial is currently recruiting participants, and it offers an opportunity to contribute to research that could improve treatment options for people with this serious condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 and ≤ 80 years old;
• • 2. Spontaneous intracerebral hemorrhage;
• • 3. Hemorrhage located in the supratentorial subcortical or basal ganglia region;
• • 4. Hematoma volume ≥ 30ml and ≤ 80ml;
• • 5. Able to undergo surgery within 72 hours after onset;
• • 6. GCS score of 5 to 14;
• • 7. The subject themselves and/or their authorized representative can understand the purpose of the study, agree to participate, and sign the informed consent form.
• Exclusion Criteria:
• • 1. History of intracerebral hemorrhage within the past year;
• • 2. Traumatic intracerebral hemorrhage;
• • 3. 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.
• • 4. Known or suspected intracerebral hemorrhage caused by tumors, aneurysms, vascular malformations, hemorrhagic transformation of ischemic stroke, cerebral venous thrombosis, etc.;
• • 5. Formation of brain herniation;
• • 6. Severe neurological or psychiatric disorders before onset (such as epilepsy, Alzheimer's disease, Parkinson's disease, schizophrenia, depression, etc.);
• • 7. mRS score ≥ 3 before onset;
• • 8. 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;
• • 9. Platelet count less than 100 × 10\^3/μL or international normalized ratio (INR) greater than 1.4;
• • 10. Active bleeding present, such as gastrointestinal bleeding, respiratory bleeding, or subcutaneous hematoma;
• • 11. Uncontrolled hypertension that cannot be managed with medication (systolic blood pressure \> 220 mmHg or diastolic blood pressure \> 120 mmHg after medication upon admission);
• • 12. Severe systemic diseases that cannot tolerate surgery, such as severe liver or kidney dysfunction;
• • 13. Women of childbearing age who are pregnant or breastfeeding;
• • 14. Currently participating in any drug or device research, or planning to participate in other drug or device clinical trials;
• • 15. Life expectancy ≤ 1 year;
• • 16. Other situations where the researcher deems the subject unsuitable for the study.