NCT07205263 RAINBOW-ICH Trial of AI Guided Minimally Invasive Neurosurgery for ICH
| NCT ID | NCT07205263 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Basal Ganglia Hemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-09-30 |
| Primary Completion | 2027-12 |
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 1,000 participants in total. It began in 2025-09-30 with a primary completion date of 2027-12.
⚠ 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
Intracerebral hemorrhage (ICH) is one of the most devastating forms of stroke, with high rates of death and disability worldwide. Despite advances in medical and surgical care, effective therapeutic options remain limited. To address this gap, the RAINBOW-ICH trial has been designed as a nationwide, multicenter, randomized umbrella trial evaluating the efficacy and safety of AI-assisted, robotic-guided minimally invasive neurosurgery compared with conventional strategies across major ICH subtypes. Under a single master protocol, RAINBOW-ICH incorporates multiple parallel randomized controlled substudies, each targeting a distinct ICH population-large basal ganglia hemorrhage, moderate basal ganglia hemorrhage, intraventricular hemorrhage, and brainstem hemorrhage. This umbrella design allows efficient use of resources while generating high-quality evidence tailored to the specific needs of different ICH subgroups, thereby supporting a more patient-centered approach to care.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07205263 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 NCT07205263 currently recruiting?
Yes, NCT07205263 is actively recruiting participants. Contact the research team at d-chengao@zju.edu.cn for enrollment information.
Where is the NCT07205263 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07205263 clinical trial?
NCT07205263 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 1,000 participants.