Robot surgeons take on strokes: a new hope for brain bleed patients?
NCT ID NCT06484374
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether using a robot to help remove large blood clots in the brain (from a hemorrhagic stroke) leads to better recovery than standard surgery. About 198 adults with a large basal ganglia hemorrhage will be randomly assigned to robot-assisted or traditional surgery. The main goal is to see if patients have less disability 6 months later.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Robot-assisted endoscopic minimally invasive surgery
- What this could lead to
- If successful, this could offer a safer, more precise surgical option for people with large brain bleeds, potentially improving recovery and reducing disability.
- What could go wrong
- This is an early-stage trial with only 198 participants, so results may not apply to everyone. The surgery itself carries risks like infection or bleeding, and the robot may not always improve outcomes over standard methods.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 198 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥18 years at randomization; 2. Diagnosed with hypertensive basal ganglia hemorrhage via imaging (CT, CTA, etc.); 3. Hematoma volume ≥30 mL prior to randomization; 4. Glasgow Coma Scale (GCS) score ≥ 5; 5. Available for surgery within 72 hours after onset; 6. Modified Rankin Scale (mRS) score ≤ 1 prior to this hemorrhage; 7. Informed consent obtained in accordance with national laws, regulations, and applicable ethics committee requirements. Exclusion Criteria: 1. Hematoma involving the thalamus (volume \>5 mL or diameter \>2 cm), midbrain, or ventricles (Graeb score ≥3), or other locations; 2. Radiologically confirmed cerebral vascular abnormalities including ruptured aneurysms, arteriovenous malformations (AVMs), or Moyamoya disease; hemorrhagic transformation of ischemic infarcts; or recent (within 1 year) recurrence of intracerebral hemorrhage; 3. Signs of impending herniation such as midline shift exceeding 1 cm or ipsilateral pupillary changes; 4. Any irreversible coagulation disorder or known coagulopathy; platelet count \<100,000; INR \>1.4; or use of anticoagulant medication within 7 days before the current hemorrhage; 5. Current or probable pregnancy; 6. Patients with concurrent severe illness likely to influence outcome assessment; 7. Difficulty in follow-up or poor compliance due to any cause.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Affiliated Drum Tower Hospital of Nanjing University Medical School
RECRUITINGNanjing, China