Using a new endoscope to treat brain bleeding

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Affiliated Hospital of Guizhou Medical University
  Guiyang, Guizhou, China Recruiting

Study contacts

• Study coordinator: Huina Lu
• Email: HuiNa.Lu@microport.com
• Phone: 021-38954600

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.