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Taking people in ChinaNo phase

Tests AI-guided robotic brain surgery for bleeding in the brain

Tests robot-guided minimally invasive surgery against standard care in adults with brain bleeding.

Plain-language title generated from the registry record
Registry title: RAINBOW-ICH Trial of AI Guided Minimally Invasive Neurosurgery for ICH

Key facts

Where
Hangzhou, ChinaSee the site

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a bleed in the brain that happened on its own (hemorrhagic stroke). It tests robot-guided keyhole brain surgery against usual care.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Spontaneous hemorrhagic stroke. Each of the four parallel studies (large or moderate basal ganglia bleed, bleed in the brain's fluid spaces, brainstem bleed) sets its own further rules.

Main reasons for not taking part

  • Abnormal blood vessels in the brain seen on imaging
  • Ischemic stroke that turned into a brain bleed
  • A repeat brain bleed within the past 1 year

Read by machine on 12 November 2026.

Where in China

  • The Second Affiliated Hospital of Zhejiang University School of MedicineHangzhou, ChinaContact: Gao Chen, MD.Taking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Second Affiliated Hospital, Zhejiang University, School of Medicine
Trial code
NCT07205263
Record updated
8 January 2026
Original description
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.Read full original descriptionShow less

A Multicenter, Randomized, Controlled, Umbrella Trial for Minimally Invasive Neurosurgery With Al-assisted Robotic Guidance for Hemorrhagic Stroke (RAINBOW-ICH)

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.

Umbrella Trial Inclusion Criteria:; Age ≥18 years;; Clinical diagnosis of spontaneous hemorrhagic stroke;; Umbrella Trial Exclusion Criteria:; 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.

ClinicalTrials.gov NCT07205263