AI-guided robotic minimally invasive neurosurgery for intracerebral hemorrhage (RAINBOW-ICH)
A Multicenter, Randomized, Controlled, Umbrella Trial for Minimally Invasive Neurosurgery With Al-assisted Robotic Guidance for Hemorrhagic Stroke (RAINBOW-ICH)
This trial will test whether AI-assisted, robotic-guided minimally invasive surgery helps adults with spontaneous intracerebral hemorrhage (including basal ganglia, intraventricular, and brainstem types) recover better than conventional care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT07205263 on ClinicalTrials.gov |
What this trial studies
RAINBOW-ICH is a nationwide, multicenter, randomized umbrella trial using a single master protocol to compare AI-assisted robotic-guided minimally invasive neurosurgical approaches with conventional surgical and medical strategies for different intracerebral hemorrhage (ICH) subtypes. Multiple parallel randomized substudies target distinct patient groups, including large and moderate basal ganglia hemorrhages, intraventricular hemorrhage, and brainstem hemorrhage. Interventions across substudies include AI-assisted robotic endoscopic hematoma evacuation, robotic-guided puncture and evacuation, ventricular evacuation plus external ventricular drainage, conventional craniotomy, and standard medical management. The design centralizes enrollment and procedures to efficiently generate randomized, subtype-specific evidence across participating tertiary centers in China.
Who should consider this trial
Good fit: Adults aged 18 or older with spontaneous intracerebral hemorrhage who meet the umbrella trial criteria and the specific inclusion/exclusion rules for one of the substudies (for example defined basal ganglia, intraventricular, or brainstem hemorrhage populations) are ideal candidates.
Not a fit: Patients whose hemorrhages are due to radiologically identified cerebrovascular abnormalities, ischemic infarction conversion, recent recurrent ICH, or who are not candidates for surgical intervention are unlikely to benefit from the robotic minimally invasive approaches tested here.
Why it matters
Potential benefit: If successful, the approach could reduce surgical trauma, improve precision of hematoma removal, and lead to better survival and functional recovery for some patients with ICH.
How similar studies have performed: Prior minimally invasive hematoma evacuation trials such as ENRICH have shown encouraging benefits for selected patients, but AI- and robot-guided approaches remain relatively novel and have limited large-scale randomized data so far.
Eligibility criteria
Show full inclusion / exclusion criteria
Umbrella Trial Inclusion Criteria: 1. Age ≥18 years； 2. Clinical diagnosis of spontaneous hemorrhagic stroke； Umbrella Trial Exclusion Criteria: 1\. Radiologically diagnosed cerebrovascular abnormalities, as well as ischemic infarction converting to intracerebral hemorrhage, or recent (within 1 year) recurrence of intracerebral hemorrhage； Each substudy will specify additional inclusion and exclusion criteria in the respective Substudy-specific Registration. Patients who fulfill the overall umbrella trial criteria will be assessed for enrollment into each substudy.
Where this trial is running
Hangzhou, Zhejiang
- The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Gao Chen, MD.
- Email: d-chengao@zju.edu.cn
- Phone: +86 0571 87784813
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.