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A multicenter study on the economic evaluation of neurosurgical surgical robots for clinical applications based on real-world data

A multicenter study on the economic evaluation of neurosurgical surgical robots for clinical applications based on real-world data

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109895
Enrollment
Unknown
Registered
2025-09-26
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trigeminal Neuralgia and Intracerebral Hemorrhage

Interventions

Control group:Neuroendoscopic Hematoma Evacuation,Percutaneous Balloon Compression Under Pure C-Arm Fluoroscopic Guidance
Research group:Robot-assisted hematoma evacuation,Robot-assisted percutaneous balloon compression (PBC)

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria for intracerebral hemorrhage: (1) The bleeding location is above the tentorium, below the tentorium, entering the ventricles, and within the brain parenchyma, where the volume of hemorrhage above the tentorium is >=30mL, and below the tentorium >=10mL; (2) There is significant neurological dysfunction and consciousness impairment with a GCS score >=6; (3) Age between 18-70 years; (4) No obvious coagulation disorders; (5) Hemorrhage duration <72h; (6) Patient or authorized family member signs the informed consent form; 2. Inclusion criteria for trigeminal neuralgia, referring to the "Expert Consensus on Microscopic Vascular Decompression for Trigeminal Neuralgia and Glossopharyngeal Neuralgia (2015)": (1) Primary trigeminal neuralgia; (2) Ineffective or intolerable adverse effects after 3 months of preoperative treatment with carbamazepine, oxcarbazepine or pregabalin; (3) Has not undergone any type of trigeminal neuralgia surgical treatment (including radiofrequency thermocoagulation, balloon compression, and microvascular decompression, etc.).

Exclusion criteria

Exclusion criteria: 1. Exclusion criteria for hemorrhage: (1) CTA examination reveals secondary causes of bleeding such as intracranial aneurysm, vascular malformation, or brain tumor strokes; (2) Patients who have brain herniation or brain death, or those with failure of other important organ functions; (3) Traumatic brain hemorrhage; (4) Patients with severe mental disorders who cannot strictly adhere to the study protocol or complete the one-year postoperative follow-up.2. Exclusion criteria for trigeminal neuralgia: (1) Patients with secondary trigeminal neuralgia; (2) Patients with comorbid pain in other areas of the face and head; (3) Patients who refuse to accept follow-up.

Design outcomes

Primary

MeasureTime frame
Barrow Neurological Institute Pain Intensity Score;Activities of Daily Living scale (ADL) scoring;Modified Rankin Scale scoring (mRS);Glasgow Coma Scale (GCS) and muscle strength assessment;

Countries

China

Contacts

Public ContactLiu Jiang

China-Japan Friendship Hospital

liujiang889@126.com+86 10 8420 5031

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026