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The decision to terminate was taken based on study team capacity not sufficient and alignment with the sponsor.
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| Name | Class |
|---|---|
| OPEN VIE Limited | UNKNOWN |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 ("new insertions cohort") | Subjects who have had Aspire SR® implanted as their first VNS model. | ||
| Cohort 2 ("battery change cohort") | Subjects who have had their VNS battery changed from a previous model to Aspire SR®. |
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| Measure | Description | Time Frame |
|---|---|---|
| Descriptive comparison of healthcare resource use (HCRU) | Descriptive comparison of secondary HCRU in the 24 month periods before and after AspireSR® device implantation | 24 months before and after device implantation |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female adult (aged ≥18 years at AspireSR® implantation) subjects with epilepsy who have had the VNS device AspireSR® implanted at least 24 months prior to study retrospective data collection.
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Wysota | The Queen Elizabeth Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Elizabeth Hospital Birmingham | Birmingham | United Kingdom |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D000069279 | Drug Resistant Epilepsy |
| D010342 | Patient Acceptance of Health Care |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000074822 | Treatment Adherence and Compliance |
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| D015438 | Health Behavior |
| D001519 | Behavior |