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RECRUITING
NCT06459427
NA

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

Sponsor: Yanbing Yu

View on ClinicalTrials.gov

Summary

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.

Official title: Robot-Assisted Minimally Invasive Surgery for Brainstem Hemorrhage

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

142

Start Date

2026-05-23

Completion Date

2028-06

Last Updated

2026-09-23

Healthy Volunteers

No

Interventions

PROCEDURE

Robot-assisted minimally invasive puncture and aspiration surgery

Positioning and surgical operation will be performed according to the robot navigation system protocols. Preoperative imaging data will be used for precise surgical planning, including the construction of a three-dimensional (3D) preoperative visualization model. The 3D reconstruction and CT data will be imported into the AI robot-assisted stereotactic system, which, after mapping to the patient's skull, automatically designs the surgical target, calculates coordinate values, plans the puncture trajectory, and determines the cranial entry point. Different surgical approaches will be selected based on the location and shape of the hematoma, and individualized parameters, including puncture direction and trajectory length, will be generated for each patient. During the procedure, the robot will assist with stereotactic puncture, while the patient's heart rate and blood pressure are closely monitored.

OTHER

Standard medical management

According to the "Chinese Neurosurgical Expert Consensus on the Diagnosis and Treatment of Primary Brainstem Hemorrhage", conventional medical treatment includes oxygen therapy, specialized nursing care, blood pressure control (maintaining BP at ≤140/90 mmHg), sedation, intracranial pressure reduction, arousal promotion, gastric protection, maintenance of internal homeostasis, infection prevention, neuro-nutrition, brain function support, nutritional support, and overall systemic management; For comatose patients, ensure a patent airway, provide nebulization and sputum clearance, prevent respiratory depression, and improve respiratory function. Closely monitor the patient's condition and provide active symptomatic treatment as needed. Regular cranial CT scans are performed to evaluate intracranial status, and in cases of ventricular hemorrhage or obstructive hydrocephalus, lateral ventricular puncture and drainage may be performed.

Locations (15)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Aerospace Center Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Hebei Provincial People's Hospital

Shijiazhuang, Hebei, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Shanghai East Hospital, Tongji University

Shanghai, Shanghai Municipality, China

Shanghai Minhang District Central Hospital

Shanghai, Shanghai Municipality, China

Jinshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, China

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Jinhua Municipal Central Hospital / Jinhua Hospital Affiliated to Zhejiang University School of Medicine

Jinhua, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China