Using a new endoscope to treat brain bleeding

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

This study is testing a new type of endoscope to see if it can safely and effectively help people with brain bleeding by removing blood clots.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: MicroPort NeuroTech Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Guiyang, Guizhou)
• Trial ID: NCT06843616 on ClinicalTrials.gov

What this trial studies

This clinical trial is a prospective, open-label, single-arm intervention aimed at evaluating the safety and effectiveness of a disposable intracerebral aspiration endoscope for treating intracerebral hematoma. The trial will enroll at least 16 subjects with spontaneous intracerebral hemorrhage, focusing on those with specific criteria regarding age, hematoma volume, and Glasgow Coma Scale scores. Participants will undergo endoscopic surgery to remove the hematoma, with follow-up assessments at discharge, one month, and three months post-operation to monitor outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 80 with spontaneous intracerebral hemorrhage located in specific brain regions and meeting certain clinical criteria.

Not a fit: Patients with a history of recent intracerebral hemorrhage, traumatic hemorrhage, or other specific conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a minimally invasive option for patients suffering from intracerebral hemorrhage, potentially improving recovery outcomes.

How similar studies have performed: While this approach is innovative, similar studies using endoscopic techniques for hematoma removal have shown promise, suggesting potential for success.

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.

Where this trial is running

Guiyang, Guizhou

• Affiliated Hospital of Guizhou Medical University — Guiyang, Guizhou, China (Recruiting)

Study contacts

• Study coordinator: Huina Lu

Conditions Intracerebral Hemorrhage