IMPACT of AspireSR® for VNS Therapy on Healthcare Resource Utilisation and Clinical Outcomes.
NCT ID: NCT05975931
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
15 participants
OBSERVATIONAL
2022-01-20
2024-01-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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Cohort 1 ("new insertions cohort")
Subjects who have had Aspire SR® implanted as their first VNS model.
No interventions assigned to this group
Cohort 2 ("battery change cohort")
Subjects who have had their VNS battery changed from a previous model to Aspire SR®.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* VNS device AspireSR® implantation for the first time or battery change from a previous model to AspireSR® at least 24 months prior to the start of retrospective data collection from medical records.
* Subjects for whom written informed consent has been provided for researcher access to their medical records and extraction of data from HES (if the subject is living and has capacity to consent) or advice from a consultee (if the subject is living but lacks capacity to consent).
* Subjects with available medical history for at least 24 months prior to Aspire SR® implantation.
Exclusion Criteria
* Deceased subjects.
18 Years
ALL
No
Sponsors
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OPEN VIE Limited
UNKNOWN
LivaNova
INDUSTRY
Responsible Party
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Principal Investigators
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Barbara Wysota
Role: PRINCIPAL_INVESTIGATOR
The Queen Elizabeth Hospital
Locations
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Queen Elizabeth Hospital Birmingham
Birmingham, , United Kingdom
Countries
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Other Identifiers
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LNE802
Identifier Type: -
Identifier Source: org_study_id