NCT06465719 A Trial for Minimally Invasive Neurosurgery With AI-assisted Robotic Guidance for Moderate Basal Ganglia Hemorrhage (RAINBOW-MBH)
| NCT ID | NCT06465719 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Condition | Basal Ganglia Hemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 330 participants |
| Start Date | 2025-09-30 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 330 participants in total. It began in 2025-09-30 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A nationwide, prospective, multicenter randomized controlled clinical trial to evaluate the therapeutic effects of the fiber tract-based artificial intelligence (AI) Robot Guiding System on the perioperative and long-term recovery of patients with moderate-volume basal ganglion hemorrhage.
Eligibility Criteria
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
Contact & Investigator
Gao Chen
PRINCIPAL INVESTIGATOR
Second Affiliated Hospital, Zhejiang University, School of Medicine
Frequently Asked Questions
Who can join the NCT06465719 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Basal Ganglia Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06465719 currently recruiting?
Yes, NCT06465719 is actively recruiting participants. Contact the research team at d-chengao@zju.edu.cn for enrollment information.
Where is the NCT06465719 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06465719 clinical trial?
NCT06465719 is sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. The principal investigator is Gao Chen at Second Affiliated Hospital, Zhejiang University, School of Medicine. The trial plans to enroll 330 participants.