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NCT06459427Recruiting

A Multicenter, RAndomIzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With AI-assisted Robotic guidanCe for Hemorrhagic Stroke

Robot-Assisted Minimally Invasive Surgery for Brainstem Hemorrhage

Source: ClinicalTrials.gov · Last updated 23 Sept 2026

Brief summary (registry, in English)

The purpose of this clinical trial is to observe the improvements in clinical symptoms and imaging outcomes for brainstem hemorrhage using robot-assisted stereotactic puncture, evaluate the clinical efficacy and safety of this treatment, and explore the development of a high-precision, intelligent, and individualized microsurgical diagnosis and treatment process for brainstem hemorrhage. The main questions it aims to address are: * Establish a multi-center clinical database for brainstem hemorrhage. * Clinically observe and evaluate the intervention effects of robot-assisted stereotactic puncture on brainstem hemorrhage, compare it with the traditional conservative treatment control group, and investigate its efficacy and impact on patient survival, motor evoked potentials, and the degree of neurological deficits. * Optimize the Artificial Intelligence (AI) algorithm-based robotic surgical assistance system, and explore the prediction of preoperative brainstem hematoma stability and hematoma path planning. Participants in the experimental group will: * Undergo robot-assisted stereotactic minimally invasive surgery for brainstem hematoma puncture * Receive conservative non-surgical treatment. If there is a control group: the researchers will compare the conservative non-surgical treatment group to evaluate the effectiveness of robot-assisted stereotactic minimally invasive surgery for brainstem hematoma puncture.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
142 (estimated)
First submitted
6 Jun 2024
Start date
23 May 2026
Primary completion date
Dec 2027
Lead sponsor
Yanbing Yu
Diseases
Stroke
NCT number
NCT06459427

What you commit to

  • Study type: Interventional
  • Planned participants: 142
  • From 23 May 2026 to the primary completion date, Dec 2027
  • 15 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • Participants must meet all of the following inclusion criteria:
  • Age ≥18 years at randomization;
  • Diagnosed with brainstem hemorrhage via imaging (CT, CTA, etc.);
  • Hematoma volume ≥3 mL;
  • Glasgow Coma Scale (GCS) score of 3-12;
  • Available for surgery within 48 hours after onset;
  • Modified Rankin Scale (mRS) score ≤ 1 prior to this hemorrhage;
  • Informed consent obtained in accordance with national laws, regulations, and applicable ethics committee requirements.
    • Patients will be excluded if they meet any of the following criteria:
  • Hematoma involving other regions such as the supratentorial compartment, basal ganglia, thalamus, midbrain, or ventricles.
  • 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;
  • Any irreversible coagulation disorder or known coagulopathy; platelet count \<100,000/µL; INR \>1.4; or use of anticoagulant medication within 7 days before the current hemorrhage;
  • Current or probable pregnancy;
  • Patients with concurrent severe illness likely to influence outcome assessment;
  • Difficulty in follow-up or poor compliance due to any cause.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Aerospace center hospital
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BeijingChinaRecruiting
China-Japan Friendship Hospital
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BeijingChinaRecruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
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HangzhouChinaRecruiting
Jinhua Municipal Central Hospital / Jinhua Hospital Affiliated to Zhejiang University School of Medicine
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JinhuaChinaRecruiting
The Second Affiliated Hospital of Nanchang University
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NanchangChinaRecruiting
Nanjing Drum Tower hospital
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NanjingChinaRecruiting
The First Affiliated Hospital of Guangxi Medical University
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NanningChinaRecruiting
Affiliated Hospital of Nantong University
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NantongChinaRecruiting
Huashan Hospital, Fudan University
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ShanghaiChinaRecruiting
Jinshan Hospital, Fudan University
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ShanghaiChinaRecruiting
Shanghai East Hospital, Tongji University
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ShanghaiChinaRecruiting
Shanghai Minhang District Central Hospital
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ShanghaiChinaRecruiting
Hebei Provincial People's Hospital
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ShijiazhuangChinaRecruiting
Tianjin Huanhu Hospital
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TianjinChinaRecruiting
The First Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.