A Multicenter, RAndomlzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al-assisted Robotic guidanCe for Hemorrhagic Stroke: Large Basal Ganglia Hemorrhage
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥18 years at randomization;
• Diagnosed with hypertensive basal ganglia hemorrhage via imaging (CT, CTA, etc.);
• Hematoma volume ≥30 mL prior to randomization;
• Glasgow Coma Scale (GCS) score ≥ 5;
• Available for surgery within 72 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.
Locations
Other Locations
China
The Affiliated Drum Tower Hospital of Nanjing University Medical School
RECRUITING
Nanjing
Contact Information
Primary
Chun-Hua Hang, PhD
hang_neurosurgery@163.com
025-83106666
Time Frame
Start Date: 2025-12-20
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 198
Treatments
Experimental: 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
Sham_comparator: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Second Affiliated Hospital, School of Medicine, Zhejiang University, Jinhua Central Hospital, Affiliated Hospital of Nantong University, The First Affiliated Hospital of Nanchang University, Minhang District Central Hospital of Shanghai, Shaoxing Central Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, Huashan Hospital, Aerospace Center Hospital, The First People's Hospital of Lianyungang, China-Japan Friendship Hospital, First Affiliated Hospital of Chongqing Medical University, The Affiliated Hospital of Inner Mongolia Medical University, The First Affiliated Hospital of Zhengzhou University, The Second Affiliated Hospital of Kunming Medical University, Jinshan Hospital Fudan University, The First Affiliated Hospital of Anhui Medical University, Renmin Hospital of Wuhan University, First Affiliated Hospital of Harbin Medical University, Hebei General Hospital, Shanghai East Hospital, First Affiliated Hospital of Guangxi Medical University
Leads: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School