Minimally invasive neurosurgery using an AI-guided robot for moderate basal ganglia hemorrhage

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 is a nationwide, prospective, multicenter randomized controlled trial comparing minimally invasive hematoma evacuation guided by a fiber tract–based AI robot to the trial comparator while all participants receive guideline-based medical care. Eligible adults with hypertensive basal ganglia hemorrhage of 15–30 mL and measurable neurologic deficits will be enrolled and randomized across participating hospitals. The AI system uses fiber-tract information to plan and guide a robotic trajectory intended to reduce damage to critical white-matter pathways during evacuation. Primary outcomes include perioperative metrics and longer-term functional recovery measured over follow-up.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years at randomization
2. Hypertensive basal ganglia hemorrhage confirmed by CT/CTA
3. Hematoma volume 15-30 mL (excluding 30 mL)
4. Functional impairment (aphasia, hemiparesis with strength ≤3, or NIHSS ≥15)
5. CT shows stable hematoma (≥6h interval, change \<5 mL)
6. GCS ≥9
7. Surgery feasible within 72h after onset
8. Pre-ICH mRS ≤1
9. Informed consent obtained according to laws and ethics

Exclusion Criteria:

1. Hematoma involving the thalamus, midbrain, or other areas
2. Radiologically diagnosed cerebrovascular abnormalities, as well as ischemic infarction converting to intracerebral hemorrhage, or recent (within 1 year) recurrence of intracerebral hemorrhage
3. Signs of impending brain herniation, such as midline shift \>1 cm or changes in the ipsilateral pupil;
4. Any irreversible coagulopathy disorders or known coagulation system disease; platelet count \<100,000; INR \>1.4; use of anticoagulants within 7 days prior to this hemorrhage;
5. Pregnant or possibly pregnant
6. Patients with severe concomitant diseases that may interfere with outcome assessment
7. Poor compliance or follow-up difficulties

Where it's running

• the Second Affiliated Hospital of Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Gao Chen — Second Affiliated Hospital, Zhejiang University, School of Medicine
• Study coordinator: Gao Chen
• Email: d-chengao@zju.edu.cn
• Phone: +86 0571-87784813

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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.