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Post-Market Active Surveillance and Health Economic Evaluation of Cerebrovascular Diagnostic and Therapeutic Devices

StatusNot Yet Recruiting
PhaseNot specified
Started
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Record History

  1. Minor Study First Submitted
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The research focuses on "post-market active surveillance and health economic evaluation of non-pharmacological therapies and innovative cerebrovascular diagnostic and therapeutic devices". Partnering with top-tier domestic institutions including the National Medical Administration Center, Regional Drug Evaluation Center, Beijing Tiantan Hospital, Capital Medical University, The First Affiliated Hospital of Naval Medical University, The First Affiliated Hospital of Harbin Medical University, and the School of Public Health, Fudan University, the project intends to: Establish standards for post-market active surveillance of cerebrovascular diagnostic and therapeutic devices and develop an intelligent surveillance system; Build a nationwide collaborative network covering multi-level medical institutions, and conduct serial cohort studies on cerebrovascular diseases based on the surveillance platform; Carry out safety, effectiveness and health economic evaluations for cerebrovascular diagnostic and therapeutic devices using data collected from the network and platform, so as to provide scientific evidence for the full-life-cycle regulation of such devices.
Trial Details
NCT Number NCT07828379
Lead Sponsor Changhai Hospital
Conditions
(from sponsor)
Acute Ischemic Stroke, Intracranial Arterial Stenosis, Extracranial Arterial Stenosis, Intracranial Aneurysms, Chronic Subdural Hematoma
Related terms Hematoma, Subdural, Chronic, Intracranial Aneurysm, Ischemic Stroke
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov