A Multicentre, RAndomlsed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al-assisted Robotic Guidance for Moderate Basal Ganglia Hemorrhage

Study Purpose

A nationwide, prospective, multicenter randomized controlled clinical trial to evaluate the therapeutic effects of the fiber tract-based artificial intelligence (AI) Robot Guiding System on the perioperative and long-term recovery of patients with moderate-volume basal ganglion hemorrhage.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age > 18. 2. Diagnosed with hypertensive basal ganglia hemorrhage (CT, CTA, etc.) 3. Hematoma volume 15

- 30mL.

4. With functional impairments (e.g., motor or sensory aphasia, muscle strength ≤ 3 in hemiparetic limbs, or NIHSS ≥ 15) 5. CT shows stable hematoma (a CT scan at least 6 hours after the diagnostic CT, with hematoma volume increase < 5 ml) 6. Randomized intervention can be initiated within 72 hours. 7. Prior mRS ≤1. 8. Patients who have Consent.

Exclusion Criteria:

1. Hematoma involving the thalamus, midbrain, or other areas. 2. Radiologically diagnosed cerebrovascular abnormalities, as well as ischemic infarction converting to intracerebral hemorrhage, or recent (within 1 year) recurrence of intracerebral hemorrhage. 3. Brain herniation. 4. Any irreversible coagulation disorders or known coagulation system diseases. 5. Patients with severe concomitant diseases that may interfere with outcome assessment. 6. Pregnancy or possible pregnancy. 7. Difficulty in follow-up or potential poor adherence due to various factors

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06465719
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Second Affiliated Hospital, School of Medicine, Zhejiang University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Gao Chen
Principal Investigator Affiliation	Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Basal Ganglia Hemorrhage

Additional Details

Basal ganglion hemorrhage is one of the most common subtypes of cerebral hemorrhage, characterized by high morbidity, mortality, and disability rates. Minimally invasive surgery for cerebral hemorrhage, particularly utilizing a fiber tract-based AI Robot Guiding System, has shown potential advantages for patient prognosis. However, there is currently no standardized practice or robust evidence confirming the effectiveness and safety of this technology for small-volume basal ganglion hemorrhage. Therefore, we are conducting a nationwide, prospective, multicenter randomized controlled clinical trial to evaluate the therapeutic effects of the fiber tract-based artificial intelligence (AI) Robot Guiding System on the perioperative and long-term recovery of patients with moderate-volume basal ganglion hemorrhage.

Arms & Interventions

Arms

Experimental: Tract-based AI Robot Guiding System Group

Patients will be operated on minimally invasive puncture and aspiration using Tract-based AI Robot guidance System

Sham Comparator: Conservative Group

Patients will be managed with guideline-based medications without surgery

Interventions

Procedure: - Minimally invasive basal ganglion hematoma evacuation with Tract-based AI Robot Guiding System

Basal ganglion hemorrhage patients will be operated on hematoma puncture and aspiration with Tract-based AI Robot Guiding System

Drug: - Patients will be managed with guideline-based medications

Patients will be managed with guideline-based medications without surgery

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hangzhou, Zhejiang, China

Status

Address

the Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009

Site Contact

Gao Chen

[email protected]

+86 0571-87784813

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