A Multicenter, RAndomlzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al-assisted Robotic guidanCe for Hemorrhagic Stroke: Large Basal Ganglia Hemorrhage

Summary

This substudy is a prospective, multicenter, parallel-controlled, randomized controlled trial designed to evaluate whether robot-assisted endoscopic evacuation of large basal ganglia hematomas can improve patient outcomes compared with traditional surgical approaches such as small craniotomy or large-bone-flap intracranial hematoma evacuation.

Conditions

• Hematoma Brain
• Large Basal Ganglia Hemorrhage

Interventions

PROCEDURE

Robot-Assisted Endoscopic Minimally Invasive Surgery

Neurosurgeons participating in the robot-assisted endoscopic procedure must be qualified doctors who have completed standardized training and certification by the coordinating center. They must be capable of performing endoscopic hematoma evacuation and managing common intraoperative complications. Each certified surgeon is required to regularly review the surgical protocol and the technical components of the procedure. Surgical trajectory: The incision and burr-hole location are determined using an AI-integrated neuroimaging automatic surgical trajectory planning system. The planning principles include, but are not limited to: avoiding critical functional areas such as language and motor cortices; avoiding vascular-dense regions; and selecting the individualized optimal trajectory based on the three-dimensional morphology and spatial orientation of the hematoma. Plan review by supporting units: All preoperative imaging data and trajectory plans are automatically stored and uploaded b

PROCEDURE

Traditional Surgical Approaches

A small craniotomy or large bone flap craniotomy is performed to microscopically evacuate the basal ganglia hematoma, followed by electrocoagulation for hemostasis. Depending on preoperative brain herniation or intraoperative brain swelling, the surgeon may decide whether to remove the bone flap.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  collaborator OTHER

• Affiliated Hospital of Nantong University

  collaborator OTHER

• The First People's Hospital of Lianyungang

  collaborator OTHER

• Huashan Hospital

  collaborator OTHER

• China-Japan Friendship Hospital

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Second Affiliated Hospital of Xi'an Jiaotong University

  collaborator OTHER

• Shaoxing Central Hospital

  collaborator OTHER

• Jinhua Central Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Shanghai East Hospital

  collaborator OTHER

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• Renmin Hospital of Wuhan University

  collaborator OTHER

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• Aerospace Center Hospital

  collaborator OTHER

• Hebei General Hospital

  collaborator OTHER

• First Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• The Affiliated Hospital of Inner Mongolia Medical University

  collaborator OTHER

• Jinshan Hospital Fudan University

  collaborator OTHER

• Minhang District Central Hospital of Shanghai

  collaborator UNKNOWN

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-20

Primary Completion

2027-06-30

Completion

2027-12-31

Countries

• China

Study Locations