Condition: Angiography, Digital Subtraction · Robot-assisted Therapy · Sponsor: The First Hospital of Hebei Medical University
This is a prospective, randomized controlled clinical trial designed to compare the safety and effectiveness of robot-assisted transradial cerebral angiography versus manual operation performed by experienced neurosurgeons. The study will be conducted at the Department of Neurosurgery, The First Hospital of Hebei Medical University, with a total sample size of 156 participants. Why is this study being done? Cerebral angiography is a key diagnostic procedure for cerebrovascular diseases, such as stroke, aneurysm, and vascular malformation. Traditionally, it is performed manually by interventional physicians, who are exposed to significant radiation during the procedure. Robot-assisted technology offers a potential solution by allowing doctors to operate from a separate, shielded room, which could greatly reduce occupational radiation exposure. This study aims to verify whether robot-assisted transradial cerebral angiography is non-inferior to the standard manual approach in terms of safety and clinical success, while providing additional benefits for both patients and physicians. Who can participate? We plan to enroll 156 adult patients (aged 18-80 years) who meet the following criteria: Stable vital signs and eligible for routine cerebral angiography Suspected intracranial vascular lesions or need for evaluation of intracranial mass blood supply, confirmed by CTA/MRA Positive Allen's test and adequate radial artery diameter (assessed by ultrasound) Able to provide informe…
This description comes directly from the study's public registry record.
Conghui Li, PhD · +8618633889708 · 13363880072@163.com
Xiangyu Meng, PhD · mengyu629@126.com
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| The First Hospital of Hebei Medical University | Shijiazhuang, Hebei, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07696936