NCT06459427From ClinicalTrials.govRecruiting

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

Brain Stem Hemorrhage
Robotic Surgical Procedures

At a glance

Phase: Phase not stated
Study type: Interventional
Sponsor: Yanbing Yu
Enrolment target: 142
Started: 23 May 2026
Main results due: December 2027
Study sites: 15
Registry updated: 23 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Participants must meet all of the following inclusion criteria:

1. Age ≥18 years at randomization；
2. Diagnosed with brainstem hemorrhage via imaging (CT, CTA, etc.)；
3. Hematoma volume ≥3 mL；
4. Glasgow Coma Scale (GCS) score of 3-12；
5. Available for surgery within 48 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.

Patients will be excluded if they meet any of the following criteria:

1. Hematoma involving other regions such as the supratentorial compartment, basal ganglia, thalamus, midbrain, or ventricles.
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. 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；
4. Current or probable pregnancy；
5. Patients with concurrent severe illness likely to influence outcome assessment；
6. Difficulty in follow-up or poor compliance due to any cause.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(15)

China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Recruiting
Aerospace Center Hospital
Beijing, Beijing Municipality, China
Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Recruiting
Hebei Provincial People's Hospital
Shijiazhuang, Hebei, China
Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Recruiting
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Recruiting
Shanghai East Hospital, Tongji University
Shanghai, Shanghai Municipality, China
Recruiting
Shanghai Minhang District Central Hospital
Shanghai, Shanghai Municipality, China
Recruiting
Jinshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Recruiting
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, China
Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Recruiting
Jinhua Municipal Central Hospital / Jinhua Hospital Affiliated to Zhejiang University School of Medicine
Jinhua, Zhejiang, China
Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Recruiting

Showing 15 of 15 sites. 15 of the 15 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06459427. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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