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

November 29, 2024 updated by: LivaNova

A Single-centre, Non-interventional, Retrospective Study to Describe the IMPACT of AspireSR® for Vagus Nerve Stimulation (VNS) Therapy on Healthcare Resource Utilisation and Clinical Outcomes.

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).

Study Overview

Status

Terminated

Conditions

Detailed 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 Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom
        • Queen Elizabeth Hospital Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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®.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Descriptive comparison of healthcare resource use (HCRU)
Time Frame: 24 months before and after device implantation
Descriptive comparison of secondary HCRU in the 24 month periods before and after AspireSR® device implantation
24 months before and after device implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LivaNova

Collaborators

OPEN VIE Limited

Investigators

  • Principal Investigator: Barbara Wysota, The Queen Elizabeth Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2022

Primary Completion (Actual)

January 30, 2024

Study Completion (Actual)

January 30, 2024

Study Registration Dates

First Submitted

July 3, 2023

First Submitted That Met QC Criteria

July 27, 2023

First Posted (Actual)

August 4, 2023

Study Record Updates

Last Update Posted (Actual)

December 3, 2024

Last Update Submitted That Met QC Criteria

November 29, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LNE802

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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