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Clinical Trial Summary

This is a retrospective non-interventional study to describe the HCRU and clinical outcomes before and after AspireSR® device implantation in subjects with drug resistant epilepsy at the Queen Elizabeth Hospital, Birmingham (QEHB).


Clinical Trial Description

Real-world data on healthcare resource use (HCRU) for subjects with treatment-resistant epilepsy and their clinical outcome prior to- and post-VNS device implantation in the UK are limited. The current study aims to describe and compare the secondary HCRU and clinical outcomes prior to and following AspireSR® device implantation in subjects with drug resistant epilepsy. Retrospectively-collected data from hospital medical records (paper-based and/or electronic, as appropriate) will be used to describe subject characteristics, disease control and clinical outcomes. All secondary HCRU data will be extracted from the Hospital Episode Statistics (HES) database by Harvey Walsh Ltd (HW, trading under OPEN VIE). Primary HCRU data will be requested from the subjects' general practitioners (GPs). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05975931
Study type Observational
Source LivaNova
Contact
Status Suspended
Phase
Start date January 20, 2022
Completion date December 2026

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