TerminatedNot Applicable

IMPACT of AspireSR® for VNS Therapy on Healthcare Resource Utilisation and Clinical Outcomes.

Stopped: The decision to terminate was taken based on study team capacity not sufficient and alignment with the sponsor.

United Kingdom15 participantsStarted 2022-01-20

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥18 years at AspireSR® device implantation. * 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: * Living subjects for whom consent for researcher access to medical records and extraction of data from HES has not been obtained. * Deceased subjects.

What they're measuring

Descriptive comparison of healthcare resource use (HCRU)

Timeframe: 24 months before and after device implantation

Trial details

NCT IDNCT05975931

SponsorLivaNova

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-01-30

View on ClinicalTrials.gov More Epilepsy trials