EpilepsyIMPACTNCT05975931
IMPACT of AspireSR® for VNS Therapy on Healthcare Resource Utilisation and Clinical Outcomes.
An observational study of Epilepsy, run by LivaNova at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jan 2022to 30 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Living subjects for whom consent for researcher access to medical records and extraction of data from HES has not been obtained.
- Deceased subjects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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).
- Conditions
- Epilepsy
- Keywords
- VNS, Drug Resistant Epilepsy, Vagus Nerve Stimulation, AspireSR®, Health Care Utilization, DRE
- Medical subject headings
- Epilepsy, Drug Resistant Epilepsy, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Descriptive comparison of healthcare resource use (HCRU)
Descriptive comparison of secondary HCRU in the 24 month periods before and after AspireSR® device implantation
Measured: 24 months before and after device implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start20 Jan 2022
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Why it stopped: The decision to terminate was taken based on study team capacity not sufficient and alignment with the sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- OPEN VIE Limited
- Responsible party
- Sponsor
- Investigators
- Barbara Wysota, Principal investigator, The Queen Elizabeth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975931
- Sponsor's protocol ID
- LNE802
- Acronym
- IMPACT
- Status last verified
- Nov 2024
- First submitted
- 3 Jul 2023
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05975931
- Acronym / sponsor ID
- IMPACT / LNE802
- Conditions
- Epilepsy
- Keywords
- VNS, Drug Resistant Epilepsy, Vagus Nerve Stimulation, AspireSR®, Health Care Utilization, DRE
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The decision to terminate was taken based on study team capacity not sufficient and alignment with the sponsor.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Collaborators
- OPEN VIE Limited
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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®. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Living subjects for whom consent for researcher access to medical records and extraction of data from HES has not been obtained.
- Deceased subjects.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study was stopped early (reason given: The decision to terminate was taken based on study team capacity not sufficient and alignment with the sponsor.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Wysota principal investigator
The Queen Elizabeth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by LivaNova at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The decision to terminate was taken based on study team capacity not sufficient and alignment with the sponsor.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive comparison of healthcare resource use (HCRU) (time frame: 24 months before and after device implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.